Cleared Traditional

K850264 - TUTTNAUER PRE-VACUUM AUTOCLAVE

K850264 is an FDA 510(k) clearance for TUTTNAUER PRE-VACUUM AUTOCLAVE, manufactured by Tuttnauer Co. , Ltd.. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K850264 · Tuttnauer Co. , Ltd. · General Hospital
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Jun 1985
Decision
132d
Days
Class 2
Risk

K850264 is an FDA 510(k) clearance for the TUTTNAUER PRE-VACUUM AUTOCLAVE. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Tuttnauer Co. , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on June 4, 1985 after a review of 132 days - within the typical 510(k) review window.

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 Tuttnauer Co. , Ltd. devices

FDA 510(k) Submission Details - K850264

510(k) Number K850264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1985
Decision Date June 04, 1985
Days to Decision 132 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
3d slower than avg
Panel avg: 129d · This submission: 132d
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 119
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K850264.
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