Transonic
627 catalogue numbers from HQC10MP, listed by Transonic Systems, Inc., United States, under Flowmeter, Blood, Cardiovascular. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
627catalogue numbers in this listing
5510(k) clearances naming this product code
10recalls on this code
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Helen of Troy Macao Limited | Macau | Guangdong | Private-label distributor | 11 |
| Dongguan Mars Medical Products Co., Ltd. | Dongguan | Guangdong | Manufacturer | 9 |
| Onbo Electronic (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Transonic Systems, Inc., United States |
|---|---|
| FDA product code | DPW |
| Device type | Flowmeter, Blood, Cardiovascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2100 |
| Establishment | Manufacturer |
| 510(k) | K872048 |
| Record published | 2020-10-08 |
| Record revised | 2021-09-14 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide, Hydrogen Peroxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2021-11-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HQC10MP | In distribution | |
| HQE6MR-S | In distribution | |
| HQC12MP | In distribution | |
| HQG2MB | In distribution | |
| HQD12XL-M20 | In distribution | |
| HQF2MU | In distribution | |
| HQD4FMV | In distribution | |
| HQC4MP | In distribution | |
| HQE6AU | In distribution | |
| HQN3MB | In distribution | |
| HQD3FME | In distribution | |
| HQE3P | In distribution | |
| HQD4XL-M7 | In distribution | |
| HQD9XL | In distribution | |
| HQD24AU | In distribution | |
| HQE4AU | In distribution | |
| HQC2MP | In distribution | |
| HQC14MP | In distribution | |
| HQF12FMV | In distribution | |
| HQD8XL | In distribution | |
| HQE3MR-S | In distribution | |
| ABLPHI | In distribution | |
| HQD36AU | In distribution | |
| HQN8FME | In distribution | |
| HQF6MR-S | In distribution | |
| HQC2FMV | In distribution | |
| HQE6FMV | In distribution | |
| HQD14FMV | In distribution | |
| HQG6MB-S | In distribution | |
| HQD6MR-S | In distribution | |
| HQD1.5FMV | In distribution | |
| HT364 | In distribution | |
| HQD6XL-M9 | In distribution | |
| HQD4FME | In distribution | |
| HQD4XL | In distribution | |
| HQF4FMC | In distribution | |
| HQC4FME | In distribution | |
| HQF4P | In distribution | |
| ABLPHS | In distribution | |
| HQF3FME | In distribution | |
| HQE2FMV | In distribution | |
| HQF36AU | In distribution | |
| HQC1.5FMV | In distribution | |
| HQC3FMV | In distribution | |
| HT360 | In distribution | |
| HQG3MB-S | In distribution | |
| HQN6FME | In distribution | |
| HQC3FMC | In distribution | |
| HQG3MB | In distribution | |
| HQC1.5FMC | In distribution | |
| HQF2MR | In distribution | |
| HQF10FMV | In distribution | |
| HQC4FMC | In distribution | |
| HQF10FME | In distribution | |
| HQD2XL | In distribution | |
| HQC8FME | In distribution | |
| HQD2FME | In distribution | |
| HQD28AU | In distribution | |
| HQC6FMV | In distribution | |
| HQC8MP | In distribution | |
| HQF2FD | In distribution | |
| HQE10FMV | In distribution | |
| HQD10AU | In distribution | |
| HQD20XL | In distribution | |
| HQD32AU | In distribution | |
| HQD10FME | In distribution | |
| HQD1.5FMC | In distribution | |
| BLF22A | In distribution | |
| HQE1.5MR | In distribution | |
| HQE2FD | In distribution | |
| HQN6MR-S | In distribution | |
| HQC2FMC | In distribution | |
| HQN2MR | In distribution | |
| HQD20AU | In distribution | |
| BLF22 | In distribution | |
| H28AUL-5 | In distribution | |
| H14AUL-5 | In distribution | |
| HQC10FMV | In distribution | |
| ABLPHE | In distribution | |
| HQD5XL-M8 | In distribution | |
| HQF20AU | In distribution | |
| HQF4FMV | In distribution | |
| HQD11XL | In distribution | |
| HQD10XL | In distribution | |
| HQD8AU | In distribution | |
| HQF1MU | In distribution | |
| HQD2XL-M4 | In distribution | |
| HQN1.5FME | In distribution | |
| HQF16AU | In distribution | |
| HQD3XL-M5 | In distribution | |
| HQE3FD | In distribution | |
| HQN6MB-S | In distribution | |
| HQC3FME | In distribution | |
| HQC1.5FME | In distribution | |
| HQD2FMV | In distribution | |
| HQF8FME | In distribution | |
| HQN3MR-S | In distribution | |
| HQF1.5MR | In distribution | |
| HQF1.5FMV | In distribution | |
| HQD2P | In distribution | |
| HQF2FMV | In distribution | |
| HQD10XL-M16 | In distribution | |
| HQE2MR | In distribution | |
| AOS1005 | In distribution | |
| HQF3FMV | In distribution | |
| HQF24AU | In distribution | |
| HQG1.5MB | In distribution | |
| HQD6FMV | In distribution | |
| HQF3MR | In distribution | |
| HQE4P | In distribution | |
| HQC8FMV | In distribution | |
| HQF2P | In distribution | |
| H16AUL-5 | In distribution | |
| HQF8FMV | In distribution | |
| HQD4FMC | In distribution | |
| HQN4MB-S | In distribution | |
| HQD16AU | In distribution | |
| HQE2P | In distribution | |
| HQF0.7MU | In distribution | |
| HQD4MR-S | In distribution | |
| HQD3FMV | In distribution | |
| HQF14AU | In distribution | |
| HQD12XL | In distribution | |
| HQE4MR-S | In distribution | |
| HQD12AU | In distribution | |
| HQF2FMC | In distribution | |
| HQN3FME | In distribution | |
| HQN2MR | In distribution | |
| HQE1.5FMV | In distribution | |
| H12AUL-5 | In distribution | |
| HQD3XL | In distribution | |
| HQE3FMV | In distribution | |
| HQD1.5MR | In distribution | |
| ABLPHR | In distribution | |
| H10AUL-5 | In distribution | |
| HQD3P | In distribution | |
| HQG4MB-S | In distribution | |
| HQD14AU | In distribution | |
| HQN2MB | In distribution | |
| HQN3MB-S | In distribution | |
| HQN2FME | In distribution | |
| HQC3MP | In distribution | |
| HT353 | In distribution | |
| HT353C | In distribution | |
| HQF1.5FMC | In distribution | |
| HQF3MR-S | In distribution | |
| HQD3MR | In distribution | |
| ABLPHDI | In distribution | |
| HQF3FD | In distribution | |
| HQD1.5FME | In distribution | |
| HQF3P | In distribution | |
| HCS6001-5 | In distribution | |
| HQN10FME | In distribution | |
| H24AUL-5 | In distribution | |
| HQF28AU | In distribution | |
| HQD5XL | In distribution | |
| HQD6XL | In distribution | |
| HQC10FME | In distribution | |
| HQD3MR-S | In distribution | |
| HQC12FMV | In distribution | |
| HQD2FMC | In distribution | |
| HQD14XL | In distribution | |
| H20AUL-5 | In distribution | |
| HT353 | In distribution | |
| HT350 | In distribution | |
| HQF6FME | In distribution | |
| HQD7XL | In distribution | |
| HQN1.5MR | In distribution | |
| HQF14FMV | In distribution | |
| HQN4FME | In distribution | |
| HQF3MU | In distribution | |
| HQD4P | In distribution | |
| HQD3FMC | In distribution | |
| HQD10FMV | In distribution | |
| HQE12FMV | In distribution | |
| HQF10AU | In distribution | |
| HQN3MR | In distribution | |
| HQC14FMV | In distribution | |
| HQE1.5FD | In distribution | |
| HQC6FME | In distribution | |
| H32AUL-5 | In distribution | |
| HQF4FD | In distribution | |
| HQF1.5FME | In distribution | |
| HQN1.5MB | In distribution | |
| HQC2FME | In distribution | |
| HQD8FME | In distribution | |
| HQE14FMV | In distribution | |
| HQD6FME | In distribution | |
| HQF4MR-S | In distribution | |
| HQD16XL | In distribution | |
| HQD4XL-M6 | In distribution | |
| H36AUL-5 | In distribution | |
| BLF21 | In distribution | |
| HQE4FD | In distribution | |
| HQD9XL-M14 | In distribution | |
| HQF1.5FD | In distribution | |
| HQC4FMV | In distribution | |
| HQE4FMV | In distribution | |
| HQF4FME | In distribution | |
| HQF8AU | In distribution | |
| HT363 | In distribution | |
| HQF6FMV | In distribution | |
| HQD12FMV | In distribution | |
| HQF1.5MU | In distribution | |
| HQD7XL-M10 | In distribution | |
| HQF32AU | In distribution | |
| HT354C | In distribution | |
| HQF3FMC | In distribution | |
| HQC6MP | In distribution | |
| HQN4MR-S | In distribution | |
| HQE3MR | In distribution | |
| HQD8FMV | In distribution | |
| HQE8FMV | In distribution | |
| HQD8XL-M12 | In distribution | |
| HQF12AU | In distribution | |
| HQF2FME | In distribution | |
| H8AUL-5 | In distribution | |
| HQE4MR-S | Withdrawn | |
| HQC20AU | Withdrawn | |
| HQE1.5FD | Withdrawn | |
| HQF6FME | Withdrawn | |
| HQN12FSB | Withdrawn | |
| HQD2FSB | Withdrawn | |
| HQE10FSB | Withdrawn | |
| HQE4FMC | Withdrawn | |
| HT310-FT | Withdrawn | |
| HQN10FSB | Withdrawn | |
| HQN1.5MB | Withdrawn | |
| HQC4FSB | Withdrawn | |
| H8AUL | Withdrawn | |
| HQD4FMC | Withdrawn | |
| HQD12FTE | Withdrawn | |
| HT360 | Withdrawn | |
| HCS6001-5 | Withdrawn | |
| HQF12FTV | Withdrawn | |
| HQC4MP | Withdrawn | |
| HQN4FTE | Withdrawn | |
| H8AUL-5 | Withdrawn | |
| HQC2FSB | Withdrawn | |
| HQD16XL | Withdrawn | |
| HQE1MU | Withdrawn | |
| HQN1.5FSB | Withdrawn | |
| HQF2FSB | Withdrawn | |
| HQC8FSB | Withdrawn | |
| HQD2XLP | Withdrawn | |
| HQC14MP | Withdrawn | |
| HQC12FTV | Withdrawn | |
| HQC1.5FMV | Withdrawn | |
| HQD10XL | Withdrawn | |
| HQC4FTE | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SonoTT Vascular Probe | Em-Tec GmbH | 12 |
| BiDop 7 probe | Koven Technology, Inc. | 8 |
| Medistim MiraQ Cardiac System | Medistim ASA | 6 |
| Medistim MiraQ Vascular System | Medistim ASA | 6 |
| FlowMet™ | Medtronic, Inc. | 4 |
| GEM Flow Coupler | Synovis Micro Companies Alliance | 4 |
| CooperSurgical® | Coopersurgical, Inc. | 4 |
| Medistim System Activation Card | Medistim ASA | 3 |
| 811-BL 24V Foreign & Domestic | Parks Medical Electronics, Inc. | 3 |
| Medistim MiraQ Ultimate System | Medistim ASA | 3 |
| Dopplex | Huntleigh Healthcare Ltd. | 3 |
| VascuChek Transceiver | Remington Medical, Inc. | 2 |
Showing 12 of 154. All products under Flowmeter, Blood, Cardiovascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140740 | 2015-07-23 |
| K112657 | 2011-12-21 |
| K033424 | 2003-12-11 |
| K903633 | 1990-10-09 |
| K872048 | 1988-06-21 |
Recalls Naming This Product
10 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Transonic Systems, Inc. | 510(k) number | 2015-07-27 | Class II | Software Manufacturing/Software Deployment | Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number. | Domestic: 4 units | 2016-07-18 |
| Transonic Systems, Inc. | 510(k) number | 2015-07-27 | Class II | Software Manufacturing/Software Deployment | Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number. | Domestic: 36 units | 2016-07-18 |
| Transonic Systems, Inc. | 510(k) number | 2015-07-27 | Class II | Software Manufacturing/Software Deployment | Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number. | Domestic: 1 unit | 2016-07-18 |
| Transonic Systems, Inc. | 510(k) number | 2015-07-27 | Class II | Software Manufacturing/Software Deployment | Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number. | Domestic: 5 units | 2016-07-18 |
| Transonic Systems, Inc. | 510(k) number | 2015-07-27 | Class II | Software Manufacturing/Software Deployment | Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number. | Domestic: 6 units | 2016-07-18 |
| Transonic Systems, Inc. | 510(k) number | 2015-07-27 | Class II | Software Manufacturing/Software Deployment | Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number. | Domestic: 6 units | 2016-07-18 |
| Transonic Systems, Inc. | 510(k) number | 2015-07-27 | Class II | Software Manufacturing/Software Deployment | Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number. | Domestic: 8 units, foreign: 11 units | 2016-07-18 |
| Transonic Systems, Inc. | 510(k) number | 2015-07-27 | Class II | Software Manufacturing/Software Deployment | Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number. | Domestic: 35 units, Foreign: 12 units | 2016-07-18 |
| Transonic Systems, Inc. | 510(k) number | 2015-07-27 | Class II | Software Manufacturing/Software Deployment | Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number. | Domestic: 15 units, Foreign: 2 units | 2016-07-18 |
| Transonic Systems, Inc. | 510(k) number | 2015-07-27 | Class II | Software Manufacturing/Software Deployment | Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number. | Domestic: 2 units | 2016-07-18 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.