Cleared Traditional

TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE (K090783) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K090783 · Tuttnauer U.S.A Co, Ltd. · General Hospital
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Aug 2009
Decision
150d
Days
Class 2
Risk

K090783 is an FDA 510(k) clearance for the TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Tuttnauer U.S.A Co, Ltd. (Washington, US). The FDA issued a Cleared decision on August 20, 2009 after a review of 150 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 Tuttnauer U.S.A Co, Ltd. devices

Submission Details

510(k) Number K090783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2009
Decision Date August 20, 2009
Days to Decision 150 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 129d · This submission: 150d
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.

Regulatory Peers - FLE Sterilizer, Steam

All 62
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K091136 · STERIS Corporation · Jun 2009
AMSCO EVOLUTION MEDIUM STEAM STERILIZER
K082435 · STERIS Corporation · Dec 2008
CLS-2000 UNIT
K024133 · Dentsply Intl. · Oct 2003