510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973106Substantially Equivalent

Golemb Disposable Bag Mask Resuscitator

Allied Medical LLC, Saint Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973106 is the FDA 510(k) clearance record for GOLEMB DISPOSABLE BAG MASK RESUSCITATOR, a class II device, cleared for Allied Healthcare Products, Inc. on under FDA product code BTM (Ventilator, Emergency, Manual (Resuscitator)). FDA records list 26 510(k) clearances for Allied Medical LLC, from to . As of , FDA records show no recalls naming K973106.

Clearance record

Decision date
Received
(163 days to decision)
Product code
BTM Ventilator, Emergency, Manual (Resuscitator)
Regulation
21 CFR 868.5915
Device class
Class II
Review panel
Anesthesiology
Applicant
Allied Healthcare Products, Inc. 1720 Sublette Ave., Saint Louis MO
510(k) summary
Statement
Third party review
No

Clearances, product code BTM

Trailing 12 months
1 clearance under product code BTM 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 BTM, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260