FDA product code SFP: Ventilator-Compatible Nebulizer
SFP is the FDA product code for ventilator-compatible nebulizer. It is a Class II device, regulated under 21 CFR 868.5630 and reviewed by the Anesthesiology panel. FDA has cleared 2 510(k) submissions under SFP, 2 in the last five years, from 2 different applicants. The average 510(k) review took 196 days (median 196); 196 days on average over the last three years.
Definition
The device is intended to deliver nebulized medications through a ventilator breathing circuit.
Classification
| Field | Value |
|---|---|
| Device name | Ventilator-Compatible Nebulizer |
| 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 SFP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 98 |
| 2026 | 1 | 293 |
Compare with all 510(k) review times · Search every SFP clearance
Top SFP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| AIRICU, Inc. | 1 | 2026-03-12 |
| Aerogen, Ltd. | 1 | 2025-09-02 |
Most recent SFP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251584 | AIRICU, Inc. | Medical Mesh Nebulizer (AirICU Max+) | 2026-03-12 | 293 |
| K251615 | Aerogen, Ltd. | Aerogen Pro-X1 Controller System | 2025-09-02 | 98 |
Recalls for SFP devices
openFDA lists no recalls for product code SFP.
Frequently asked questions
What is FDA product code SFP?
SFP is the FDA product code for ventilator-compatible nebulizer. It is a Class II device, regulated under 21 CFR 868.5630 and reviewed by the Anesthesiology panel.
What device class is SFP?
Class II, regulation 21 CFR 868.5630. Typical premarket route: 510(k).
How long does a 510(k) take for product code SFP?
Across 2 cleared submissions the average was 196 days from receipt to decision (median 196).
Which companies have the most SFP clearances?
AIRICU, Inc. (1); Aerogen, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SFP
- Run a recall and safety report across every SFP manufacturer
- Watch product code SFP 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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