510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K924468Substantially Equivalent

Sterile Instrument Trays/basin Sets

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

K924468 is the FDA 510(k) clearance record for STERILE INSTRUMENT TRAYS/BASIN SETS, a class II device, cleared for Baxter Healthcare Corp on under FDA product code LRO (General Surgery Tray). FDA's definition for product code LRO reads: "This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the...". FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K924468.

Clearance record

Decision date
Received
(310 days to decision)
Product code
LRO General Surgery Tray
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Baxter Healthcare Corp 7280 N. Caldwell, Niles IL
510(k) summary
Summary
Third party review
No

Clearances, product code LRO

Trailing 12 months

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

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