FDA product code CAH: Filter, Bacterial, Breathing-Circuit
CAH is the FDA product code for filter, bacterial, breathing-circuit. It is a Class II device, regulated under 21 CFR 868.5260 and reviewed by the General Hospital panel. FDA has cleared 202 510(k) submissions under CAH, 10 in the last five years, from 126 different applicants. The average 510(k) review took 127 days (median 88); 325 days on average over the last three years. FDA has posted 28 recalls for CAH devices, 17 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Filter, Bacterial, Breathing-Circuit |
| Device class | Class II |
| Regulation | 21 CFR 868.5260 |
| Review panel | HO — General Hospital |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for CAH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 120 |
| 2019 | 2 | 320 |
| 2020 | 2 | 210 |
| 2021 | 2 | 299 |
| 2022 | 3 | 261 |
| 2023 | 3 | 235 |
| 2024 | 2 | 346 |
| 2026 | 2 | 304 |
Compare with all 510(k) review times · Search every CAH clearance
Top CAH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Intersurgical, Inc. | 9 | 2012-11-02 |
| Medipart Jerry Alexander | 8 | 1986-08-01 |
| Porous Media Corp. | 6 | 2006-06-05 |
| King Systems Corp. | 5 | 2001-10-09 |
| Mallinckrodt Medical | 5 | 1996-11-26 |
121 more applicants have CAH clearances. See the full list in Caduvo.
Most recent CAH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252643 | Teleflex Medical Sdn. Bhd. | Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled | 2026-05-15 | 267 |
| K251583 | Ambu A/S | Ambu® Virobac II® Exhalation Filter | 2026-04-30 | 342 |
| K241339 | Besmed Health Business Corp | Besmed Bacterial Filter and HMEF | 2024-11-14 | 185 |
| K222917 | Shaoxing Haitech Medical Products Co., Ltd. | Breathing circuit bacterial/viral filter | 2024-02-15 | 507 |
| K230483 | Passy-Muir, Inc. | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) | 2023-09-16 | 205 |
Recalls for CAH devices
28 product recalls in 16 recall events; 17 initiated in the last five years and 21 still open. Most recent: 2025-10-10.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2021 | 4 |
| 2022 | 7 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 7 |
Frequently asked questions
What is FDA product code CAH?
CAH is the FDA product code for filter, bacterial, breathing-circuit. It is a Class II device, regulated under 21 CFR 868.5260 and reviewed by the General Hospital panel.
What device class is CAH?
Class II, regulation 21 CFR 868.5260. Typical premarket route: 510(k).
How long does a 510(k) take for product code CAH?
Across 202 cleared submissions the average was 127 days from receipt to decision (median 88).
Which companies have the most CAH clearances?
Intersurgical, Inc. (9); Medipart Jerry Alexander (8); Porous Media Corp. (6); King Systems Corp. (5); Mallinckrodt Medical (5).
Have CAH devices been recalled?
Yes: 28 product recalls across 16 recall events; the most recent began 2025-10-10.
Next steps
- Run an FDA pathway report with predicate devices for product code CAH
- Run a recall and safety report across every CAH manufacturer
- Watch product code CAH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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