Hygrobac,S Hygroboy and Hygrobaby
FDA 510(k) K941381 · Mallinckrodt Medical
510(k) numberK941381
Submission
- Device name
- Hygrobac,S Hygroboy and Hygrobaby
- Applicant
- Mallinckrodt Medical
Argyle, NY, US - Received
- March 22, 1994
- Decision date
- April 15, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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 |
|---|---|---|
| K082520 | Sealguard Evac Endotracheal and Endotracheal TubesBTR · Special | 10/02/2008SE |
| K051416 | Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Inner CannulaJOH · Special | 06/16/2005SE |
| K972258 | Hi-Care Closed Suction SystemBSY · Traditional | 12/29/1997SE |
| K971267 | Shiley Extended Length, Disposable Cannula, Tracheostomy Tube: Cuffed, Distal Extension…JOH · Traditional | 09/25/1997SE |
| K963732 | Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low Profile Cuff and…JOH · Traditional | 06/26/1997SE |
| K955721 | Cuffed Oropharyngeal Airway (Copa)CAE · Traditional | 03/28/1997SE |
| K965132 | Hi-Lo Evac and Evac II Endotracheal TubesBTR · Traditional | 03/20/1997SE |
| K962045 | Anesthesia Breathing Circuit/Anesthesia Breathing KitCAH · Traditional | 11/26/1996SE |
| K962173 | Shikey Tracheostomy Tubes and AccessoriesJOH · Traditional | 10/04/1996SE |
| K955680 | Shiley Cuffed Pediatric Tracheostomy Tube; Long CuffedJOH · Traditional | 03/13/1996SE |
Questions and answers
When was Hygrobac,S Hygroboy and Hygrobaby cleared by the FDA?
Hygrobac,S Hygroboy and Hygrobaby (K941381) received a 510(k) decision of Substantially Equivalent on April 15, 1994, 24 days after the submission was received.
What is the product code of K941381?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.