Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5630](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5630) → SFP — Ventilator-Compatible Nebulizer

# SFP · Ventilator-Compatible Nebulizer

_Anesthesiology · 21 CFR 868.5630 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/SFP

## Overview

- **Product Code:** SFP
- **Device Name:** Ventilator-Compatible Nebulizer
- **Regulation:** [21 CFR 868.5630](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5630)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K251584](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/SFP/K251584.md) | Medical Mesh Nebulizer (AirICU Max+) | AIRICU, Inc. | Mar 12, 2026 | SESE |
| [K251615](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/SFP/K251615.md) | Aerogen Pro-X1 Controller System | Aerogen, Ltd. | Sep 2, 2025 | SESE |

## Top Applicants

- AIRICU, Inc. — 1 clearance
- Aerogen, Ltd. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/SFP](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/SFP)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com