510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K965016Substantially Equivalent

ISO-Gard Filter Angled(18212)/iso-Gard Filter Straight(19212)

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

K965016 is the FDA 510(k) clearance record for ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212), a class II device, cleared for Gibeck, Inc. on under FDA product code CAH (Filter, Bacterial, Breathing-Circuit). FDA records list 15 510(k) clearances for Gibeck, Inc., from to . As of , FDA records show 6 recalls naming K965016.

Clearance record

Decision date
Received
(351 days to decision)
Product code
CAH Filter, Bacterial, Breathing-Circuit
Regulation
21 CFR 868.5260
Device class
Class II
Review panel
Anesthesiology
Applicant
Gibeck, Inc. 10640 E. 59th St., Indianapolis 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