510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K131455Substantially Equivalent

Restore Modular Sterilization Tray System

Restore Medical Solutions, Inc., Chevy Chase MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131455 is the FDA 510(k) clearance record for RESTORE MODULAR STERILIZATION TRAY SYSTEM, a class II device, cleared for Restore Medical Solutions, Inc. on under FDA product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories). FDA records list one 510(k) clearance for Restore Medical Solutions, Inc. As of , FDA records show no recalls naming K131455.

Clearance record

Decision date
Received
(102 days to decision)
Product code
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Restore Medical Solutions, Inc. 5600 Wisconsin Ave., # 509, Chevy Chase MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KCT

Trailing 12 months
8 clearances under product code KCT in the twelve months to October 2026, June 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code KCT, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20262
March 20260
April 20260
May 20260
June 20263
July 20260
August 20260
September 20262
October 20260