510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091363Substantially Equivalent

Compressor Filter, Models Ag1038831, Hcf100,bf900,bf910,bf950, Ll201, Ll202, Ll205, Bacteria Filter

AG Industries LLC, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091363 is the FDA 510(k) clearance record for COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER, a class II device, cleared for Ag Industries on under FDA product code CAH (Filter, Bacterial, Breathing-Circuit). FDA records list 2 510(k) clearances for Ag Industries, from to . As of , FDA records show no recalls naming K091363.

Clearance record

Decision date
Received
(272 days to decision)
Product code
CAH Filter, Bacterial, Breathing-Circuit
Regulation
21 CFR 868.5260
Device class
Class II
Review panel
Anesthesiology
Applicant
Ag Industries 1705. Capital Of Texas Hwy., Austin TX
510(k) summary
Summary PDF
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