510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K871686Substantially Equivalent

Gem-Crit Check

Diamond Sensor Systems, Ann Arbor MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871686 is the FDA 510(k) clearance record for GEM-CRIT CHECK, a class II device, cleared for Diamond Sensor Systems on under FDA product code DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass). FDA records list 3 510(k) clearances for Diamond Sensor Systems, from to . As of , FDA records show no recalls naming K871686.

Clearance record

Decision date
Received
(50 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
Diamond Sensor Systems 1230 Eisenhower Pl., Ann Arbor MI
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