510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781145Substantially Equivalent

Monitor Kits, Blood Level

3M Health Care, Sarns, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781145 is the FDA 510(k) clearance record for MONITOR KITS, BLOOD LEVEL, a class II device, cleared for 3M Health Care, Sarns on under FDA product code DTW (Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass). FDA records list 76 510(k) clearances for 3M Health Care, Sarns, from to . As of , FDA records show no recalls naming K781145.

Clearance record

Decision date
Received
(17 days to decision)
Product code
DTW Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Regulation
21 CFR 870.4340
Device class
Class II
Review panel
Cardiovascular
Applicant
3M Health Care, Sarns 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DTW

Trailing 12 months

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

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