Cleared Traditional

K850264 - TUTTNAUER PRE-VACUUM AUTOCLAVE

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

K850264 · Tuttnauer Co. , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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.