Filter SafeStar 60a Plus
The SafeStar 60A Plus is a breathing-system filter used with ventilators and anaesthesia machines to limit bacterial and viral contamination. It is a mechanical filter intended for adult…
The SafeStar 60A Plus is a breathing-system filter used with ventilators and anaesthesia machines to limit bacterial and viral contamination. It is a mechanical filter intended for adult patients and is used by trained medical personnel.
Filter material is enclosed within a housing that connects to standard breathing-system connectors. Gas passes through the filter in either direction, allowing filtration of inhaled or exhaled breathing gases in the circuit.
Duration of Use
The filter is intended for a single use of up to 24 hours. It provides filtration rather than the passive humidification function of the separately identified TwinStar filter and heat-and-moisture exchanger products.
Who Else Makes It
Concentrated in Jiangsu (6), Guangdong (4), Zhejiang (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 21 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 12 |
| GVS Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
Showing 12 of 15. All 15 manufacturers in China registered for Filter, Bacterial, Breathing-Circuit
Record
| Listed by | Drägerwerk AG & Co. KGaA, Germany |
|---|---|
| FDA product code | CAH |
| Device type | Filter, Bacterial, Breathing-Circuit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5260 |
| 510(k) | K221836 |
| Record published | 2023-01-09 |
| Record revised | 2026-01-23 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2025-07-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MP05795 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 405 |
| Pulmoguard | S D I Diagnostics Inc | 203 |
| Cardinal Health | Cardinal Health 200, LLC | 131 |
| DAR | Covidien LP | 110 |
| Portex | ICU Medical, Inc | 108 |
| Vital Signs™ | SunMed Group Holdings, LLC | 78 |
| Pentair | Pentair Filtration Solutions | 68 |
| Disposable Anesthesia Circuits | Westmed, Inc. | 68 |
| AirLife™ | AirLife Finland Oy | 43 |
| Ventlab | Ventlab, LLC | 40 |
| VBMax | A-M Systems | 39 |
| Vital Signs™ | AirLife Finland Oy | 38 |
Showing 12 of 545. All products under Filter, Bacterial, Breathing-Circuit
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221836 | 2022-12-07 |
Recalls Naming This Product
4 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 |
|---|---|---|---|---|---|---|
| Draeger, Inc. | 510(k) number | 2025-06-16 | Class I | Process control | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. | 669,838 units |
| Draeger, Inc. | 510(k) number | 2025-06-16 | Class I | Process control | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. | 9,885,139 units |
| Draeger, Inc. | 510(k) number | 2025-06-16 | Class I | Process control | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. | 1,019,782 units |
| Draeger, Inc. | 510(k) number | 2025-06-16 | Class I | Process control | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. | 374,700 units |
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.