510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K920837Substantially Equivalent

Sterile Convertor Safecare Gown and Drape

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

K920837 is the FDA 510(k) clearance record for STERILE CONVERTOR SAFECARE GOWN AND DRAPE, a class II device, cleared for Baxter Healthcare Corp on under FDA product code FYA (Gown, Surgical). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K920837.

Clearance record

Decision date
Received
(88 days to decision)
Product code
FYA Gown, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Baxter Healthcare Corp 1500 Waukegan Rd., Waukegan IL
510(k) summary
Statement
Third party review
No

Clearances, product code FYA

Trailing 12 months
10 clearances under product code FYA in the twelve months to November 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FYA, trailing twelve months
MonthClearances
December 20251
January 20260
February 20262
March 20260
April 20262
May 20261
June 20261
July 20261
August 20262
September 20260
October 20260
November 20260