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
K874436Substantially Equivalent

Fluid Sampling Pack

U.S. Mfg. & Management, Inc., San Bernardino CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874436 is the FDA 510(k) clearance record for FLUID SAMPLING PACK, a class I device, cleared for U.S. Mfg. & Management, Inc. on under FDA product code KSS (Supplies, Blood-Bank). FDA records list 5 510(k) clearances for U.S. Mfg. & Management, Inc., from to . As of , FDA records show no recalls naming K874436.

Clearance record

Decision date
Received
(69 days to decision)
Product code
KSS Supplies, Blood-Bank
Regulation
21 CFR 864.9050
Device class
Class I
Review panel
Hematology
Applicant
U.S. Mfg. & Management, Inc. 287 S. Stoddard Ave., San Bernardino CA
Third party review
No

Clearances, product code KSS

Trailing 12 months

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

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