510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153540Substantially Equivalent

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators

Safe Secure Packaging Co., Ltd., Shenzhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153540 is the FDA 510(k) clearance record for Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators, a class II device, cleared for Safe Secure Packaging Co., Ltd. on under FDA product code FRG (Wrap, Sterilization). FDA records list 2 510(k) clearances for Safe Secure Packaging Co., Ltd., from to . As of , FDA records show 43 recalls naming K153540.

Clearance record

Decision date
Received
(238 days to decision)
Product code
FRG Wrap, Sterilization
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Safe Secure Packaging Co., Ltd. #4 Chengguang Industrial Park, Shenzhen, CN
510(k) summary
Summary PDF
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