510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SFPClass II

Ventilator-Compatible Nebulizer

21 CFR 868.5630 / Anesthesiology
FDA source (opens on fda.gov)

SFP is the FDA product code for Ventilator-Compatible Nebulizer, a class II device type, regulated under 21 CFR 868.5630. FDA's definition for this code reads: "The device is intended to deliver nebulized medications through a ventilator breathing circuit". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SFP
Device name
Ventilator-Compatible Nebulizer
FDA definition
The device is intended to deliver nebulized medications through a ventilator breathing circuit.
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code SFP

By decision year
2 clearances under product code SFP with a decision year between 2025 and 2026, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SFP by decision year
YearClearances
20251
20261

Applicants with the most clearances

Product code SFP
Applicants holding the most 510(k) clearances under product code SFP
ApplicantClearances
Airicu Inc.1
Aerogen Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code