Cleared Traditional

K920478 - TUTTNAUER LSI (AUTOMATIC)

K920478 is the FDA 510(k) clearance for TUTTNAUER LSI (AUTOMATIC) by Tuttnauer Co. , Ltd.. It is a Class 2 General Hospital device (product code FLE) cleared through the Traditional 510(k) pathway after a 526-day FDA review.

K920478 · Tuttnauer Co. , Ltd. · General Hospital
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Jul 1993
Decision
526d
Days
Class 2
Risk

K920478 is an FDA 510(k) clearance for the TUTTNAUER LSI (AUTOMATIC). Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Tuttnauer Co. , Ltd. (Ronkonkoma, US). The FDA issued a Cleared decision on July 8, 1993 after a review of 526 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Tuttnauer Co. , Ltd. devices

Submission Details

510(k) Number K920478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1992
Decision Date July 08, 1993
Days to Decision 526 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
397d slower than avg
Panel avg: 129d · This submission: 526d
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.