510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K200334Substantially Equivalent

AN1036 Dosimeter

Andersen Sterilizers, Inc., Haw River NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200334 is the FDA 510(k) clearance record for AN1036 Dosimeter, a class II device, cleared for Andersen Sterilizers, Inc. on under FDA product code JOJ (Indicator, Physical/Chemical Sterilization Process). FDA records list 19 510(k) clearances for Andersen Sterilizers, Inc., from to . As of , FDA records show no recalls naming K200334.

Clearance record

Decision date
Received
(275 days to decision)
Product code
JOJ Indicator, Physical/Chemical Sterilization Process
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
Andersen Sterilizers, Inc. 3154 Caroline Dr., Haw River NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JOJ

Trailing 12 months
3 clearances under product code JOJ in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JOJ, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260