Flotrac
Flotrac Sensor JR
7manufacturers in China registered for this device type
2catalogue numbers in this listing
3510(k) clearances naming this product code
7recalls on this code
Who Else Makes It
Concentrated in Guangdong (5), Zhejiang (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 21 |
| Unimed Medical Supplies Inc | Shenzhen | Guangdong | Contract manufacturer | 15 |
| Shenzhen Antmed Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | Edwards Lifesciences Technology Sarl, United States |
|---|---|
| FDA product code | DRS |
| Device type | Transducer, Blood-Pressure, Extravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2850 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K231248 |
| Record published | 2024-08-06 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in a cool, dry place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MHD6JR | In distribution | |
| MHD8JR | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 381 |
| Medex | ICU Medical, Inc | 225 |
| Biotrans™ Pressure Monitoring Kits | Bioptimal International Pte. Ltd. | 134 |
| Transpac™ | ICU Medical, Inc | 117 |
| Antmed | Shenzhen Antmed Co., Ltd. | 96 |
| Namic | Navilyst Medical, Inc. | 60 |
| Namic | Medline Industries, Inc. | 58 |
| Transpac™/Transtar™ | ICU Medical, Inc | 58 |
| Merit Medical® | Argon Critical Care Systems Singapore PTE. Ltd. | 28 |
| Centurion | Centurion Medical Products Corporation | 23 |
| Transducer, Blood-Pressure, Extravascular | Utah Medical Products, Inc. | 22 |
| Deltran | Utah Medical Products, Inc. | 22 |
Showing 12 of 145. All products under Transducer, Blood-Pressure, Extravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242909 | 2025-03-21 |
| K152980 | 2016-01-19 |
| K043065 | 2005-01-26 |
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-10-04 | Class II | Device Design | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | 168,014 units | |
| 2023-10-04 | Class II | Device Design | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | 1417 units | |
| 2023-10-04 | Class II | Device Design | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | 118,570 units | |
| 2023-10-04 | Class II | Device Design | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | 6,714 units | |
| 2023-10-04 | Class II | Device Design | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | 11,072 units | |
| 2023-10-04 | Class II | Device Design | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | 33,327 units | |
| 2013-07-31 | Class II | Packaging process control | The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance related to incorrect packaging configuration where the IFU was placed on top of the Tyvek instead of being placed at the bottom of the box. The | 35 units | 2017-04-14 |
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.