510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K951331Substantially Equivalent

Accusport Lactate Monitoring System Lactate Test Strips Accusport Monitor

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

K951331 is the FDA 510(k) clearance record for ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR, a class I device, cleared for Boehringer Mannheim Corp. on under FDA product code KHP (Acid, Lactic, Enzymatic Method). FDA records list 340 510(k) clearances for Boehringer Mannheim Corp., from to . As of , FDA records show no recalls naming K951331.

Clearance record

Decision date
Received
(140 days to decision)
Product code
KHP Acid, Lactic, Enzymatic Method
Regulation
21 CFR 862.1450
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Boehringer Mannheim Corp. 9115 Hague Rd., P.O. Box 50457, Indianapolis IN
510(k) summary
Summary
Third party review
No

Clearances, product code KHP

Trailing 12 months

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

FDA records show no clearances under product code KHP in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KHP, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260