Respirgard II, Spirogard
FDA 510(k) K961838 · Marquest Medical Products, Inc.
510(k) numberK961838
Submission
- Device name
- Respirgard II, Spirogard
- Applicant
- Marquest Medical Products, Inc.
Englewood, CO, US - Received
- May 13, 1996
- Decision date
- October 18, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K050066 | C-CO2 Colorimetric CO2 IndicatorCCK · Traditional | 03/01/2005SE |
| K970478 | SCT 3000 Heated HumidifierBTT · Traditional | 07/16/1997SE |
| K962223 | Water Chambers for ST 3000 Heated HumidifierBTT · Traditional | 01/14/1997SE |
| K962220 | Heated Wire Circuits for SCT 3000 Heated HumidifierBZE · Traditional | 01/14/1997SE |
| K960972 | Disposable Gas Sampling Interface KitsCCK · Traditional | 10/18/1996SE |
| K904690 | Temp Marq(Tm) Convective Warming SystemDWJ · Traditional | 02/01/1991SE |
| K903138 | Marquest SCT 3000, Heated Humidification SystemBTT · Traditional | 10/11/1990SE |
| K902632 | Gas-Lyte 1CC and 3CC Arterial Blood SamplersCBT · Traditional | 09/04/1990SE |
| K903307 | Temp Marq Temperature Trend IndicatorKPD · Traditional | 08/17/1990SE |
| K880979 | Marquest SCT 2000, Heated Humidification SystemBTT · Traditional | 07/15/1988SE |
Questions and answers
When was Respirgard II, Spirogard cleared by the FDA?
Respirgard II, Spirogard (K961838) received a 510(k) decision of Substantially Equivalent on October 18, 1996, 158 days after the submission was received.
What is the product code of K961838?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.