System One Humidifier
System One Heated Tube Humidifier, H and L
18manufacturers in China registered for this device type
6catalogue numbers in this listing
67510(k) clearances naming this product code
35recalls on this code
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (2), Zhejiang (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Suzhou Avon Textile Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 12 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Hunan Beyond Medical Technology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 3 |
| Shanghai Baron Technologies Co Ltd | Shanghai | Shanghai | Contract manufacturer | 3 |
| BMC(Dongguan) Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Zhejiang Baron Technologies Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 1 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Shenzhen Sany Pioneer Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Resvent Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
Showing 12 of 18. All 18 manufacturers in China registered for Ventilator, Non-Continuous (Respirator)
Record
| Listed by | Respironics Inc., United States |
|---|---|
| FDA product code | BZD |
| Device type | Ventilator, Non-Continuous (Respirator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K091319 |
| Record published | 2017-02-07 |
| Record revised | 2022-10-27 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment temperature -4 to 140 °F; Storage environment humidity 15 to 95 % RH |
| Distribution end date | 2022-10-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| System One Heated Humidifier, IT | In distribution | |
| System One Heated Humidifier, DE | In distribution | |
| System One Heated Tube Humidifier, H&L | In distribution | |
| System One Heated Tube Humidifier, IT | In distribution | |
| System One REMstar Heated Humidifier | Withdrawn | |
| System One Heated Tube Humidifier, CN | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DreamStation | Respironics Inc. | 386 |
| DreamWear | Respironics Inc. | 183 |
| REMstar System One 60 Series | Respironics Inc. | 163 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 152 |
| DeVilbiss | DeVilbiss Healthcare LLC. | 136 |
| Ventilator, Non-Continuous (Respirator) | Hans Rudolph, Inc. | 115 |
| BiPAP System One 60 Series | Respironics Inc. | 105 |
| Ventilator, Non-Continuous (Respirator) | Salter Labs | 85 |
| BiTrac Select | Pulmodyne Inc. | 79 |
| Yuwell Sleep Apnea Breathing Therapy Mask | Suzhou Yuyue Medical Technology Co., Ltd. | 76 |
| AF541 | Respironics Inc. | 71 |
| CPAP Masks | Sunset Healthcare Solutions, Inc. | 69 |
Showing 12 of 699. All products under Ventilator, Non-Continuous (Respirator)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231313 | 2023-07-28 |
| K210844 | 2021-08-24 |
| K210386 | 2021-07-12 |
| K201439 | 2020-09-25 |
| K200480 | 2020-07-10 |
| K183226 | 2019-10-18 |
| K181053 | 2019-01-04 |
| K151120 | 2016-04-15 |
| K152356 | 2016-01-08 |
| K150639 | 2015-09-18 |
| K140980 | 2015-02-10 |
| K142554 | 2015-01-09 |
| K140268 | 2014-10-20 |
| K132168 | 2013-11-20 |
| K131982 | 2013-10-18 |
| K130077 | 2013-05-21 |
| K122847 | 2013-03-06 |
| K122769 | 2012-10-09 |
| K121631 | 2012-10-05 |
| K120562 | 2012-07-17 |
| K120145 | 2012-03-30 |
| K113068 | 2011-12-16 |
| K110405 | 2011-06-06 |
| K103395 | 2011-03-24 |
| K110008 | 2011-02-17 |
| K102502 | 2010-12-22 |
| K091112 | 2009-05-15 |
| K082558 | 2009-03-25 |
| K072996 | 2007-12-27 |
| K061034 | 2006-06-23 |
| K053352 | 2006-02-15 |
| K052110 | 2005-10-20 |
| K050759 | 2005-06-15 |
| K043607 | 2005-01-28 |
| K041010 | 2004-05-05 |
| K032834 | 2004-03-04 |
| K033759 | 2004-02-19 |
| K031460 | 2003-06-24 |
| K021861 | 2002-06-19 |
| K012554 | 2002-01-29 |
| K011714 | 2001-06-28 |
| K010263 | 2001-03-29 |
| K002465 | 2000-09-08 |
| K000705 | 2000-09-08 |
| K000994 | 2000-06-22 |
| K992969 | 1999-11-10 |
| K993433 | 1999-10-27 |
| K993307 | 1999-10-27 |
| K992336 | 1999-08-13 |
| K991648 | 1999-05-28 |
| K963761 | 1997-04-18 |
| K964363 | 1997-01-30 |
| K962203 | 1996-12-05 |
| K963250 | 1996-11-14 |
| K953930 | 1996-09-30 |
| K961915 | 1996-08-15 |
| K961626 | 1996-07-18 |
| K954572 | 1996-06-26 |
| K945938 | 1996-01-31 |
| K954207 | 1996-01-31 |
| K953341 | 1996-01-30 |
| K936047 | 1995-03-29 |
| K925587 | 1993-09-14 |
| K925920 | 1993-07-21 |
| K920699 | 1992-12-07 |
| K911856 | 1991-08-09 |
| K905540 | 1991-01-30 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Respironics Inc. | 510(k) number | 2021-06-14 | Class I | Device Design | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals. | 15,357,775 (10,307,186 in US, 5,039,748 OUS) in total |
Recalls
9 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-06-30 | Class I | Process control | Devices may possess a programming error resulting in an incorrect device configuration. | 28 units | |
| 2025-06-30 | Class I | Process control | Devices may possess a programming error resulting in an incorrect device configuration. | 57 units | |
| 2025-06-30 | Class I | Process control | Devices may possess a programming error resulting in an incorrect device configuration. | 8 units | |
| 2023-02-10 | Class I | Software design (manufacturing process) | A limited number of remediated Philips DreamStation units may experience communication issues when connecting to the cloud-based care management application. Should this be the case, this may affect the ability to download prescription sett | 1233 devices | |
| 2022-09-06 | Class I | Error in labeling | No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. | 930,813 units | |
| 2022-09-06 | Class I | Error in labeling | No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. | 9,191,280 units | |
| 2022-09-06 | Class I | Error in labeling | No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. | 42,954 units | |
| 2022-09-06 | Class I | Error in labeling | No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. | 5,661,639 units | |
| 2022-09-06 | Class I | Error in labeling | No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. | 6,237,558 units | |
| 2009-02-05 | Not classified | Nonconforming Material/Component | Malfunction of the J3 connection between the Heater Plate Main printed circuit assembly (PCA) and the heater plate may have an intermittent connection which may lead to excessive heat build-up on the humidifier PCA. | 449,585 units | 2012-07-05 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2003-09-29 | Not classified | Other | product does not contain built in exhalation port | 5293 units | 2004-03-01 |
| 2003-09-29 | Not classified | Other | product does not contain built in exhalation port | 5293 units | 2004-03-01 |
| 2003-09-29 | Not classified | Other | product does not contain built in exhalation port | 5293 units | 2004-03-01 |
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.