510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K953938Substantially Equivalent

Sterilemax

Barnstead/Thermolyne Corp., Dubuque IA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953938 is the FDA 510(k) clearance record for STERILEMAX, a class II device, cleared for Barnstead/Thermolyne Corp. on under FDA product code FLE (Sterilizer, Steam). FDA records list 2 510(k) clearances for Barnstead/Thermolyne Corp., from to . As of , FDA records show no recalls naming K953938.

Clearance record

Decision date
Received
(528 days to decision)
Product code
FLE Sterilizer, Steam
Regulation
21 CFR 880.6880
Device class
Class II
Review panel
General Hospital
Applicant
Barnstead/Thermolyne Corp. 2555 Kerper Blvd., Dubuque IA
510(k) summary
Summary
Third party review
No

Clearances, product code FLE

Trailing 12 months
4 clearances under product code FLE 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 FLE, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20261
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260