510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K897171Substantially Equivalent

Disposable CO2 Absorber/e

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

K897171 is the FDA 510(k) clearance record for DISPOSABLE CO2 ABSORBER/E, a class I device, cleared for Gibeck, Inc. on under FDA product code CBL (Absorbent, Carbon-Dioxide). FDA records list 15 510(k) clearances for Gibeck, Inc., from to . As of , FDA records show no recalls naming K897171.

Clearance record

Decision date
Received
(75 days to decision)
Product code
CBL Absorbent, Carbon-Dioxide
Regulation
21 CFR 868.5300
Device class
Class I
Review panel
Anesthesiology
Applicant
Gibeck, Inc. 10640 E. 59th St., Indianapolis IN
Third party review
No

Clearances, product code CBL

Trailing 12 months

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

FDA records show no clearances under product code CBL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CBL, 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