510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K894031Unknown

Pharmaseal Genetic Amniocentesis Tray

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

K894031 is the FDA 510(k) clearance record for PHARMASEAL GENETIC AMNIOCENTESIS TRAY, a class I device, cleared for Baxter Healthcare Corp on under FDA product code HIO (Sampler, Amniotic Fluid (Amniocentesis Tray)). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K894031.

Clearance record

Decision date
Received
(59 days to decision)
Product code
HIO Sampler, Amniotic Fluid (Amniocentesis Tray)
Regulation
21 CFR 884.1550
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Baxter Healthcare Corp 27200 N. Tourney Rd., Valencia CA
Third party review
No

Clearances, product code HIO

Trailing 12 months

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

FDA records show no clearances under product code HIO in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HIO, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260