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
K001287Substantially Equivalent

Empty Reservoir Bag, 50 Ml,100 Ml,250 Ml,500 Ml, 1000M Ml, 1500 Ml, 2000 Ml, 3000 Ml

Sorenson Medical, Inc., West Jordan UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001287 is the FDA 510(k) clearance record for EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML, a class II device, cleared for Sorenson Medical, Inc. on under FDA product code KPE (Container, I.V.). FDA records list 6 510(k) clearances for Sorenson Medical, Inc., from to . As of , FDA records show no recalls naming K001287.

Clearance record

Decision date
Received
(46 days to decision)
Product code
KPE Container, I.V.
Regulation
21 CFR 880.5025
Device class
Class II
Review panel
General Hospital
Applicant
Sorenson Medical, Inc. 1375 W. 8040 S., West Jordan UT
510(k) summary
Statement
Third party review
No

Clearances, product code KPE

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