510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011586Substantially Equivalent

Irma Sl Blood Analysis System Gl Cartridge

Diametrics Medical, Inc., Roseville MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011586 is the FDA 510(k) clearance record for IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE, a class I device, cleared for Diametrics Medical, Inc. on under FDA product code GAA (Needle, Aspiration And Injection, Disposable). FDA records list 11 510(k) clearances for Diametrics Medical, Inc., from to . As of , FDA records show no recalls naming K011586.

Clearance record

Decision date
Received
(177 days to decision)
Product code
GAA Needle, Aspiration And Injection, Disposable
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Diametrics Medical, Inc. 2658 Patton Rd., Roseville MN
510(k) summary
Summary
Third party review
No

Clearances, product code GAA

Trailing 12 months

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

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