510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K780410Substantially Equivalent

Blood Pump-Mode S10k

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

K780410 is the FDA 510(k) clearance record for BLOOD PUMP-MODE S10K, a class II device, cleared for 3M Health Care, Sarns on under FDA product code FIR (Pump, Blood, Extra-Luminal). FDA records list 76 510(k) clearances for 3M Health Care, Sarns, from to . As of , FDA records show no recalls naming K780410.

Clearance record

Decision date
Received
(51 days to decision)
Product code
FIR Pump, Blood, Extra-Luminal
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
3M Health Care, Sarns 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FIR

Trailing 12 months

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

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