FDA product code CAF: Nebulizer (Direct Patient Interface)
CAF is the FDA product code for nebulizer (direct patient interface). It is a Class II device, regulated under 21 CFR 868.5630 and reviewed by the Anesthesiology panel. FDA has cleared 509 510(k) submissions under CAF, 25 in the last five years, from 254 different applicants. The average 510(k) review took 159 days (median 123); 217 days on average over the last three years. FDA has posted 36 recalls for CAF devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Nebulizer (Direct Patient Interface) |
| Device class | Class II |
| Regulation | 21 CFR 868.5630 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
510(k) clearances per year for CAF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 8 | 289 |
| 2018 | 9 | 220 |
| 2019 | 3 | 265 |
| 2020 | 6 | 295 |
| 2021 | 8 | 314 |
| 2022 | 4 | 169 |
| 2023 | 8 | 320 |
| 2024 | 4 | 248 |
| 2025 | 7 | 205 |
| 2026 | 2 | 197 |
Compare with all 510(k) review times · Search every CAF clearance
Top CAF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Airlife, Inc. | 16 | 1983-12-12 |
| Vortran Medical Technology 1, Inc. | 12 | 1996-12-16 |
| Adherium (Nz), Ltd. | 10 | 2023-02-08 |
| Salter Labs | 9 | 2002-02-01 |
| Pari Respiratory Equipment, Inc. | 8 | 2025-12-19 |
249 more applicants have CAF clearances. See the full list in Caduvo.
Most recent CAF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254171 | Shenzhen Mericonn Technology Co., Ltd. | Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) | 2026-09-18 | 269 |
| K260270 | FindAir Sp. z o.o. | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) | 2026-06-02 | 125 |
| K251572 | Pari Respiratory Equipment, Inc. | eRapid with eTrack System | 2025-12-19 | 211 |
| K251659 | Qingdao Future Medical Technology Co., Ltd. | Mesh Nebulizer (H6) | 2025-11-14 | 168 |
| K244035 | Shenzhen Jermei Medical Device Technology Co., Ltd. | Portable mesh nebulizer (JM821) | 2025-09-19 | 263 |
Recalls for CAF devices
36 product recalls in 20 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-08-04.
| Year | Recalls |
|---|---|
| 2017 | 14 |
| 2018 | 1 |
| 2021 | 1 |
| 2023 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- G0379 — Direct admission of patient for hospital observation care
Frequently asked questions
What is FDA product code CAF?
CAF is the FDA product code for nebulizer (direct patient interface). It is a Class II device, regulated under 21 CFR 868.5630 and reviewed by the Anesthesiology panel.
What device class is CAF?
Class II, regulation 21 CFR 868.5630. Typical premarket route: 510(k).
How long does a 510(k) take for product code CAF?
Across 509 cleared submissions the average was 159 days from receipt to decision (median 123).
Which companies have the most CAF clearances?
Airlife, Inc. (16); Vortran Medical Technology 1, Inc. (12); Adherium (Nz), Ltd. (10); Salter Labs (9); Pari Respiratory Equipment, Inc. (8).
Have CAF devices been recalled?
Yes: 36 product recalls across 20 recall events; the most recent began 2023-08-04.
Next steps
- Run an FDA pathway report with predicate devices for product code CAF
- Run a recall and safety report across every CAF manufacturer
- Watch product code CAF 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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