510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901442Substantially Equivalent

Baxter D & C Tray

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

K901442 is the FDA 510(k) clearance record for BAXTER D & C TRAY, a class I device, cleared for Baxter Healthcare Corp on under FDA product code HCY (Curette, Uterine). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show one recall naming K901442.

Clearance record

Decision date
Received
(121 days to decision)
Product code
HCY Curette, Uterine
Regulation
21 CFR 884.4530
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Baxter Healthcare Corp 7280 N. Caldwell, Niles IL
Third party review
No

Clearances, product code HCY

Trailing 12 months

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

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