510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K822441Substantially Equivalent

Unimeter 330K

Boehringer Mannheim Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822441 is the FDA 510(k) clearance record for UNIMETER 330K, a class II device, cleared for Boehringer Mannheim Corp. on under FDA product code CEM (Electrode, Ion Specific, Potassium). FDA records list 340 510(k) clearances for Boehringer Mannheim Corp., from to . As of , FDA records show no recalls naming K822441.

Clearance record

Decision date
Received
(53 days to decision)
Product code
CEM Electrode, Ion Specific, Potassium
Regulation
21 CFR 862.1600
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Boehringer Mannheim Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CEM

Trailing 12 months
1 clearance under product code CEM in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CEM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260