510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K844649Substantially Equivalent

Electrically Heated Sterilizer Steam Sterilizer

Takizawa Medical Instruments Manufacturer, New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844649 is the FDA 510(k) clearance record for ELECTRICALLY HEATED STERILIZER STEAM STERILIZER, a class II device, cleared for Takizawa Medical Instruments Manufacturer on under FDA product code FLE (Sterilizer, Steam). FDA records list one 510(k) clearance for Takizawa Medical Instruments Manufacturer. As of , FDA records show no recalls naming K844649.

Clearance record

Decision date
Received
(249 days to decision)
Product code
FLE Sterilizer, Steam
Regulation
21 CFR 880.6880
Device class
Class II
Review panel
General Hospital
Applicant
Takizawa Medical Instruments Manufacturer 570 Lexington Ave., New York NY
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