Pressure Tubing and Accessories
FDA 510(k) K901816 · Arbo Medical, Inc.
510(k) numberK901816
Submission
- Device name
- Pressure Tubing and Accessories
- Applicant
- Arbo Medical, Inc.
Ann Arbor, MI, US - Received
- April 23, 1990
- Decision date
- July 12, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAH – Filter, Bacterial, Breathing-Circuit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5260
- Specialty
- Anesthesiology
Other 510(k)s with product code CAH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K940323 | Arbo Diagnostic ECG Patient Cables & Leadwires Arbo Shielded Multi-Lead Cable & Lead…DSA · Traditional | 04/12/1995SE |
| K935437 | Arbo H85V/H87V/H27V Dispos Monit ElectrodesDRX · Traditional | 04/06/1995SE |
| K942905 | Disposable Temperature Probe CoverFMT · Traditional | 02/27/1995SE |
| K940302 | Arbo Monitring Safety Cable & Lead Wire Systems/Arbo Unsheilded Safety Cable & Lead SystemDSA · Traditional | 11/30/1994SE |
| K940322 | Arbo VS Monitor Cable & Leadwire System Arbo Shielded Safety Cable & Lead WireDSA · Traditional | 11/28/1994SE |
| K935246 | Arbo H49P, H59P Disposable Monitoring ElectrodesDRX · Traditional | 11/16/1994SE |
| K935429 | Arbo H90, H91, H135 Disposable Monitoring ElectrodesDRX · Traditional | 11/01/1994SE |
| K935281 | Arbo H87P, H85P, H27P Disposable Monitoring ElectrodesDRX · Traditional | 09/06/1994SE |
| K905545 | Ultrasound Transmission GelJOT · Traditional | 03/29/1991SE |
| K902788 | Clem TMFIB · Traditional | 09/12/1990SE |
Questions and answers
When was Pressure Tubing and Accessories cleared by the FDA?
Pressure Tubing and Accessories (K901816) received a 510(k) decision of Substantially Equivalent on July 12, 1990, 80 days after the submission was received.
What is the product code of K901816?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.