Specialty Packaging Prod Bacterial/Viral Filter
FDA 510(k) K922492 · Specialty Packaging Producs, Inc.
510(k) numberK922492
Submission
- Device name
- Specialty Packaging Prod Bacterial/Viral Filter
- Applicant
- Specialty Packaging Producs, Inc.
El Paso, TX, US - Received
- May 27, 1992
- Decision date
- August 24, 1992
- 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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|---|---|---|---|
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K913163 | Non Rebreathing ValveCBP · Traditional | 02/03/1992SE |
| K913422 | Oxygen Tubing, 81503BYX · Traditional | 01/30/1992SE |
| K913216 | Trach T AdapterBZA · Traditional | 01/15/1992SE |
| K913164 | Non Rebreathing MaskKGB · Traditional | 01/15/1992SE |
| K913421 | Nasal Oxygen Cannula, 81585, 81587 & 81589CAT · Traditional | 10/18/1991SE |
| K913383 | Oxygen Masks 81420, 81421, 81471 & 81461BYG · Traditional | 10/18/1991SE |
| K913275 | Venturi Oxygen MaskBYG · Traditional | 10/10/1991SE |
| K913220 | Aerosol Masks, 81426, 81476, 81490 & 81492CAF · Traditional | 10/10/1991SE |
| K913455 | Oxygen Masks 82400 & 82405BYG · Traditional | 10/02/1991SE |
| K910896 | Disposable Anesthesia Breathing CircuitCAI · Traditional | 05/08/1991SE |
Questions and answers
When was Specialty Packaging Prod Bacterial/Viral Filter cleared by the FDA?
Specialty Packaging Prod Bacterial/Viral Filter (K922492) received a 510(k) decision of Substantially Equivalent on August 24, 1992, 89 days after the submission was received.
What is the product code of K922492?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.