Prima Filter
FDA 510(k) K952015 · Prima, Inc.
510(k) numberK952015
Submission
- Device name
- Prima Filter
- Applicant
- Prima, Inc.
Cleveland, TN, US - Received
- April 28, 1995
- Decision date
- May 22, 1995
- 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 |
|---|---|---|
| K952022 | Prima Volumn VentilatorssBZO · Traditional | 05/22/1995SE |
| K952021 | Prima Hyuperinflation SystemBZR · Traditional | 05/22/1995SE |
| K952020 | Prima Pediatric Anesthesia CircuitsCAI · Traditional | 05/22/1995SE |
| K952019 | Prima Adult Gas Sampling CircuitsCAI · Traditional | 05/22/1995SE |
| K952018 | Prima Coaxial CircuitsCAI · Traditional | 05/22/1995SE |
| K952017 | Prima Mapleson D CircuitCAI · Traditional | 05/22/1995SE |
| K952016 | Prima Pediatric Gas Sampling CircuitsCAI · Traditional | 05/22/1995SE |
| K952014 | Prima Adult Temperature Monitoring Anesthesia CircuitsCAI · Traditional | 05/22/1995SE |
| K952013 | Prima Guedel AirwaysBTR · Traditional | 05/22/1995SE |
| K952012 | Prima Custom Anestesia CircuitBZO · Traditional | 05/22/1995SE |
Questions and answers
When was Prima Filter cleared by the FDA?
Prima Filter (K952015) received a 510(k) decision of Substantially Equivalent on May 22, 1995, 24 days after the submission was received.
What is the product code of K952015?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.