510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150639Substantially Equivalent

AF541 EE Full Face Mask

Respironics, Inc., Murrysville PA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150639 is the FDA 510(k) clearance record for AF541 EE Full Face Mask, a class II device, cleared for Respironics, Inc. on under FDA product code BZD (Ventilator, Non-Continuous (Respirator)). FDA records list 186 510(k) clearances for Respironics, Inc., from to . As of , FDA records show no recalls naming K150639.

Clearance record

Decision date
Received
(191 days to decision)
Product code
BZD Ventilator, Non-Continuous (Respirator)
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
Respironics, Inc. 1001 Murry Ridge Ln., Murrysville PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZD

Trailing 12 months
11 clearances under product code BZD in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BZD, trailing twelve months
MonthClearances
November 20250
December 20252
January 20262
February 20260
March 20260
April 20262
May 20262
June 20261
July 20261
August 20260
September 20261
October 20260