Mini-Filter, Virobac II
FDA 510(k) K880681 · King Systems Corp.
510(k) numberK880681
Submission
- Device name
- Mini-Filter, Virobac II
- Applicant
- King Systems Corp.
Noblesville, IN, US - Received
- February 19, 1988
- Decision date
- April 29, 1988
- 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 |
|---|---|---|
| K033189 | King LTS Reusable Oropharyngeal Airway with Drain/Suction Channel, Models KLT 303, KLT…CAE · Special | 05/04/2004SE |
| K033186 | King Lt-D Disposable Oropharyngeal Airway, Models KLT 203, KLT 204 and KLT 205CAE · Special | 04/14/2004SE |
| K021634 | King LT, Models # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105CAE · Traditional | 01/09/2003SE |
| K012485 | MS-140 All-Round Enhanced Performance Filter; MS-141 All-Round Enhanced Performance…CAH · Traditional | 10/09/2001SE |
| K010040 | Sleeved FilterCAH · Traditional | 03/09/2001SE |
| K990614 | Hme-BoosterBTT · Traditional | 05/23/2000SE |
| K983817 | Breathing Circuit Bacterial Filter/Heat and Moisture Exchanger (Hme/F)CAH · Traditional | 03/01/1999SE |
| K973797 | Breathing Circuit Bacterial FilterCAH · Traditional | 03/12/1998SE |
| K953513 | Xenon CircuitIYT · Traditional | 11/03/1995SE |
| K951093 | Kab SystemBSF · Traditional | 03/24/1995SE |
Questions and answers
When was Mini-Filter, Virobac II cleared by the FDA?
Mini-Filter, Virobac II (K880681) received a 510(k) decision of Substantially Equivalent on April 29, 1988, 70 days after the submission was received.
What is the product code of K880681?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.