510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K954142Substantially Equivalent

Sterradd Sterilization System

Advanced Sterilization Products, Irvin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954142 is the FDA 510(k) clearance record for STERRADD STERILIZATION SYSTEM, a class II device, cleared for Advanced Sterilization Products on under FDA product code FLE (Sterilizer, Steam). FDA records list 59 510(k) clearances for Advanced Sterilization Products, from to . As of , FDA records show no recalls naming K954142.

Clearance record

Decision date
Received
(644 days to decision)
Product code
FLE Sterilizer, Steam
Regulation
21 CFR 880.6880
Device class
Class II
Review panel
General Hospital
Applicant
Advanced Sterilization Products 33 Technology Dr., Irvin CA
510(k) summary
Statement
Third party review
No

Clearances, product code FLE

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