510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K912920Substantially Equivalent

Sarns Sm03 Membrane Oxygenator W/ Integrated Reser

3M Company, Ann Arbor MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912920 is the FDA 510(k) clearance record for SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER, a class II device, cleared for 3M Health Care, Ltd. on under FDA product code DTZ (Oxygenator, Cardiopulmonary Bypass). FDA records list 58 510(k) clearances for 3M COMPANY, from to . As of , FDA records show no recalls naming K912920.

Clearance record

Decision date
Received
(84 days to decision)
Product code
DTZ Oxygenator, Cardiopulmonary Bypass
Regulation
21 CFR 870.4350
Device class
Class II
Review panel
Cardiovascular
Applicant
3M Health Care, Ltd. 6200 Jackson Rd., Ann Arbor MI
510(k) summary
Statement
Third party review
No

Clearances, product code DTZ

Trailing 12 months
4 clearances under product code DTZ in the twelve months to November 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DTZ, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20262
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260