Electrostatic Hydrophobic Breathing Filter
FDA 510(k) K002201 · Sims Portex, Inc.
510(k) numberK002201
Submission
- Device name
- Electrostatic Hydrophobic Breathing Filter
- Applicant
- Sims Portex, Inc.
Keene, NH, US - Received
- July 20, 2000
- Decision date
- February 5, 2001
- 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 |
|---|---|---|
| K012277 | Portex Ring Pessary Pvc-Non Sterile; Portex Ring Pessary Polythene- Non SterileHHW · Traditional | 02/11/2002SE |
| K012068 | Wallace Oocyte Retrieval Sets 16G, Wallace Oocyte Retrieval Set 17G, Models Meons 1633S…MQE · Traditional | 08/03/2001SE |
| K011925 | Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic Needle-Pro…FMI · Traditional | 07/12/2001SE |
| K002506 | Breathing Filter for Disposable Anesthesia Breathing CircuitCAH · Traditional | 12/14/2000SE |
| K001555 | Suresample-Wallace Endometrial Sampler, Endo 26HHK · Traditional | 08/02/2000SE |
| K001318 | CPAP System, Model 102001BYE · Traditional | 07/20/2000SE |
| K993619 | Csecure Combined Spinal/Epidural Anesthesia System with LockBSP · Traditional | 04/28/2000SE |
| K000628 | Wallace Oocyte Retrieval SET-16G, Model MEONS1633; Wallace Oocyte Retrieval SET-17G…MQE · Traditional | 03/13/2000SE |
| K994275 | Sims Portex Anesthesia CatheterFRN · Traditional | 02/22/2000SE |
| K991861 | 1ST Response Infant Manual Resuscitator, Bag Resevoir, 1ST Response Pediatric Manual…BTM · Traditional | 01/18/2000SE |
Questions and answers
When was Electrostatic Hydrophobic Breathing Filter cleared by the FDA?
Electrostatic Hydrophobic Breathing Filter (K002201) received a 510(k) decision of Substantially Equivalent on February 5, 2001, 200 days after the submission was received.
What is the product code of K002201?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.