510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K875166Substantially Equivalent

Pharmaseal Sterile Umbilical Cord Clamp

Baxter Healthcare Corporation, Valencia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875166 is the FDA 510(k) clearance record for PHARMASEAL STERILE UMBILICAL CORD CLAMP, a class I device, cleared for Baxter Healthcare Corp on under FDA product code HWI (Corkscrew). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K875166.

Clearance record

Decision date
Received
(76 days to decision)
Product code
HWI Corkscrew
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Baxter Healthcare Corp 27200 N. Tourney Rd., Valencia CA
Third party review
No

Clearances, product code HWI

Trailing 12 months

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

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