510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K042991Substantially Equivalent

I-Neb Aad System

Profile Therapeutics PLC, Murrysville PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042991 is the FDA 510(k) clearance record for I-NEB AAD SYSTEM, a class II device, cleared for Profile Therapeutics Plc on under FDA product code CAF (Nebulizer (Direct Patient Interface)). FDA records list 3 510(k) clearances for Profile Therapeutics Plc, from to . As of , FDA records show no recalls naming K042991.

Clearance record

Decision date
Received
(326 days to decision)
Product code
CAF Nebulizer (Direct Patient Interface)
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Applicant
Profile Therapeutics Plc Corporate Services, Murrysville PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CAF

Trailing 12 months
4 clearances under product code CAF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CAF, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260