510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K014282Substantially Equivalent

Bacstop Filter,bacstop Filter/hme

Munktell Filter AB, Mccordsville IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K014282 is the FDA 510(k) clearance record for BACSTOP FILTER,BACSTOP FILTER/HME, a class II device, cleared for Munktell Filter AB on under FDA product code CAH (Filter, Bacterial, Breathing-Circuit). FDA records list 2 510(k) clearances for Munktell Filter AB. As of , FDA records show no recalls naming K014282.

Clearance record

Decision date
Received
(181 days to decision)
Product code
CAH Filter, Bacterial, Breathing-Circuit
Regulation
21 CFR 868.5260
Device class
Class II
Review panel
Anesthesiology
Applicant
Munktell Filter AB 6329 W. Waterview Ct., Mccordsville IN
510(k) summary
Summary
Third party review
No

Clearances, product code CAH

Trailing 12 months
2 clearances under product code CAH in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CAH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260