Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55
FDA 510(k) K072002 · Draeger Medical AG & Co. KG
510(k) numberK072002
Submission
- Device name
- Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55
- Applicant
- Draeger Medical AG & Co. KG
Telford, PA, US - Received
- July 23, 2007
- Decision date
- January 31, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAH – Filter, Bacterial, Breathing-Circuit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5260
- Specialty
- Anesthesiology
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| K252643 | Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledCAH · Traditional | Teleflex Medical Sdn. Bhd. | 05/15/2026SE |
| K251583 | Ambu® Virobac II® Exhalation FilterCAH · Traditional | Ambu A/S | 04/30/2026SE |
| K241339 | Besmed Bacterial Filter and HMEFCAH · Traditional | Besmed Health Business Corp | 11/14/2024SE |
| K222917 | Breathing circuit bacterial/viral filterCAH · Traditional | Shaoxing Haitech Medical Products Co., Ltd. | 02/15/2024SE |
| K230483 | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)CAH · Traditional | Passy-Muir, Inc. | 09/16/2023SE |
| K223258 | TNI Clear-Guard 3 angled breathing filter (1545020)CAH · Traditional | Intersurgical , Ltd. | 06/15/2023SE |
| K221472 | Filter and HME/FilterCAH · Traditional | Ningbo Huakun Medical Equipment Co., Ltd. | 02/08/2023SE |
| K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusCAH · Traditional | Drägerwerk AG & Co. KGaA | 12/07/2022SE |
| K221250 | EasyOne FilterCAH · Traditional | Ndd Medizintechnik AG | 11/22/2022SE |
| K210352 | GGM Breathing Circuit Bacterial FilterCAH · Traditional | Great Group Medical Co, Ltd. | 03/27/2022SE |
More from Great Group Medical Co, Ltd.
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| K121999 | General Purpose Temperature Probe, Skin Temperature ProbeFLL · Traditional | 02/28/2013SE |
| K103035 | Smartpilot View Model MK04500BSZ · Traditional | 03/28/2012SE |
| K102618 | Ventstar Heated, Infinity Id Breathing Circuit HeatedBTT · Traditional | 12/10/2010SE |
| K092029 | Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310BYE · Traditional | 08/06/2010SE |
| K100941 | Infinity Mcable - Mainstream CO2CCK · Special | 04/23/2010SE |
| K092999 | NBP CuffDXQ · Traditional | 11/24/2009SE |
| K083050 | Evite XLCBK · Special | 12/29/2008SE |
| K081447 | Fourth Gas Module with CO2 for Primus US ApolloBSZ · Traditional | 10/08/2008SE |
Questions and answers
When was Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55 cleared by the FDA?
Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55 (K072002) received a 510(k) decision of Substantially Equivalent on January 31, 2008, 192 days after the submission was received.
What is the product code of K072002?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.