510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K932584Substantially Equivalent

Breathing Bags

Merit Medical Systems, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932584 is the FDA 510(k) clearance record for BREATHING BAGS, a class I device, cleared for Merit Medical Systems, Inc. on under FDA product code BTC (Bag, Reservoir). FDA records list 204 510(k) clearances for Merit Medical Systems, Inc., from to . As of , FDA records show no recalls naming K932584.

Clearance record

Decision date
Received
(50 days to decision)
Product code
BTC Bag, Reservoir
Regulation
21 CFR 868.5320
Device class
Class I
Review panel
Anesthesiology
Applicant
Merit Medical Systems, Inc. 8102 Woodland Dr/., Indianapolis IN
510(k) summary
Statement
Third party review
No

Clearances, product code BTC

Trailing 12 months

FDA records hold no clearances under product code BTC in the trailing twelve months.

FDA records show no clearances under product code BTC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BTC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260