510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893519Substantially Equivalent

Twin-Fusor/uni-Fusor Blood & Fluid Infusion Cuff

Statlabs, Inc., Franklin TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893519 is the FDA 510(k) clearance record for TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF, a class I device, cleared for Statlabs, Inc. on under FDA product code KZB (Automated Colony Counter). FDA records list one 510(k) clearance for Statlabs, Inc. As of , FDA records show 11 recalls naming K893519.

Clearance record

Decision date
Received
(99 days to decision)
Product code
KZB Automated Colony Counter
Regulation
21 CFR 866.2170
Device class
Class I
Review panel
Microbiology
Applicant
Statlabs, Inc. 169 London Ln., Franklin TN
Third party review
No

Clearances, product code KZB

Trailing 12 months

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

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