510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K030853Substantially Equivalent

Steritite Perforated Base Rigid Reusable Sterilization Container System with Scf02-Polypropylene Non-Woven Disposable Fi

Case Medical, Inc., Ridgefield NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030853 is the FDA 510(k) clearance record for STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI, a class II device, cleared for Case Medical, Inc. on under FDA product code FRG (Wrap, Sterilization). FDA records list 16 510(k) clearances for Case Medical, Inc., from to . As of , FDA records show one recall naming K030853.

Clearance record

Decision date
Received
(3 days to decision)
Product code
FRG Wrap, Sterilization
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Case Medical, Inc. 65 Railroad Ave., Ridgefield NJ
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