510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103321Substantially Equivalent

Dana Reusable Testpack for Steam Sterilization for 10 Minute Extended Cycles

Dana Products, Inc., South Barrington IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K103321 is the FDA 510(k) clearance record for DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES, a class II device, cleared for Dana Products, Inc. on under FDA product code FRC (Indicator, Biological Sterilization Process). FDA records list 9 510(k) clearances for Dana Products, Inc., from to . As of , FDA records show no recalls naming K103321.

Clearance record

Decision date
Received
(96 days to decision)
Product code
FRC Indicator, Biological Sterilization Process
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
Dana Products, Inc. 7 Corey Dr., South Barrington IL
510(k) summary
Statement
Third party review
No

Clearances, product code FRC

Trailing 12 months
1 clearance under product code FRC in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FRC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260