Cleared Traditional

K844649 - ELECTRICALLY HEATED STERILIZER STEAM STERILIZER

K844649 is an FDA 510(k) clearance for ELECTRICALLY HEATED STERILIZER STEAM ST..., manufactured by Takizawa Medical Instruments Manufacturer. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K844649 · Takizawa Medical Instruments Manufacturer · General Hospital
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Aug 1985
Decision
249d
Days
Class 2
Risk

K844649 is an FDA 510(k) clearance for the ELECTRICALLY HEATED STERILIZER STEAM STERILIZER. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Takizawa Medical Instruments Manufacturer (New York, US). The FDA issued a Cleared decision on August 5, 1985 after a review of 249 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Takizawa Medical Instruments Manufacturer devices

FDA 510(k) Submission Details - K844649

510(k) Number K844649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1984
Decision Date August 05, 1985
Days to Decision 249 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 129d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLE Device Classification - Class 2, Special Controls

Product Code FLE Sterilizer, Steam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLE Sterilizer, Steam

All 140
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K844649.
MITEK STERILIZATION TRAY
K893886 · Mitek Surgical Products, Inc. · Aug 1989
REBUILDING STERILIZERS
K882713 · Mdt Corp., Inc. · Aug 1988
MODIFIED CASTLE POWERCLAVE
K870975 · Castle Co. · Apr 1987
RITTER STERILIZER
K801309 · Sybron Corp. · Jun 1980
STERILIZING CASE CAT. NO. 65199
K800080 · Edward Weck, Inc. · Jan 1980
STERILIZER, EAGLE 2000
K781684 · American Sterilizer Co. · Oct 1978