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
K861277Substantially Equivalent

Critichem Continuous Blood Gas Montitor, Cvgm-1000

Critichem, Inc., Little Falls NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861277 is the FDA 510(k) clearance record for CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000, a class II device, cleared for Critichem, Inc. on under FDA product code DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass). FDA records list one 510(k) clearance for Critichem, Inc. As of , FDA records show no recalls naming K861277.

Clearance record

Decision date
Received
(56 days to decision)
Product code
DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Regulation
21 CFR 870.4330
Device class
Class II
Review panel
Cardiovascular
Applicant
Critichem, Inc. 49 Sindle Ave., Little Falls NJ
Third party review
No

Clearances, product code DRY

Trailing 12 months

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

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