510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K032827Substantially Equivalent

Kendall Lifetrace Umbilical Blood Collection Kit, Code 56501

Tyco Healthcare, Mansfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032827 is the FDA 510(k) clearance record for KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501, a class II device, cleared for Tyco Healthcare on under FDA product code KSR (Container, Empty, For Collection & Processing Of Blood & Blood Components). FDA records list 14 510(k) clearances for Tyco Healthcare, from to . As of , FDA records show no recalls naming K032827.

Clearance record

Decision date
Received
(89 days to decision)
Product code
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components
Regulation
21 CFR 864.9100
Device class
Class II
Review panel
Hematology
Applicant
Tyco Healthcare 15 Hampshire St., Mansfield MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KSR

Trailing 12 months

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

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