510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953678Substantially Equivalent

Sterimed Sterization Wrapper (Non-Sterile)

Customed, Inc, Fajardo PR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953678 is the FDA 510(k) clearance record for STERIMED STERIZATION WRAPPER (NON-STERILE), a class II device, cleared for Customed, Inc. on under FDA product code FRG (Wrap, Sterilization). FDA records list 37 510(k) clearances for Customed, Inc., from to . As of , FDA records show no recalls naming K953678.

Clearance record

Decision date
Received
(56 days to decision)
Product code
FRG Wrap, Sterilization
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Customed, Inc. Calle Industrial Final, Hvy., Fajardo PR
510(k) summary
Statement
Third party review
No

Clearances, product code FRG

Trailing 12 months
5 clearances under product code FRG in the twelve months to October 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FRG, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20262
June 20260
July 20261
August 20260
September 20260
October 20260