Cleared Traditional

K833837 - AMERICAN GOLD SERIES AUTOCLAVE

K833837 is an FDA 510(k) clearance for AMERICAN GOLD SERIES 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 69-day FDA review.

K833837 · Tuttnauer Co. , Ltd. · General Hospital
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Jan 1984
Decision
69d
Days
Class 2
Risk

K833837 is an FDA 510(k) clearance for the AMERICAN GOLD SERIES AUTOCLAVE. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Tuttnauer Co. , Ltd. (Walker, US). The FDA issued a Cleared decision on January 11, 1984 after a review of 69 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K833837

510(k) Number K833837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1983
Decision Date January 11, 1984
Days to Decision 69 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 129d · This submission: 69d
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 177
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K833837.
STARCRAFT ELITE AUTOCLAVE
K862495 · Starcraft Medical Corp. · Oct 1986
STEAM STERILIZER
K831356 · Ars Enterprises, Inc. · Jul 1984
ETHYLENE OXIDE DETECTOR GLD-1-07
K834152 · Calnor of EL Paseo, Inc. · Mar 1984
PORTABLE AUTOCLAVES
K830931 · Arnold & Sons · Jul 1983
NON-PRESSURE AUTOCLAVE FOR STERILIZATION
K823457 · Interdent, Inc. · Feb 1983
STEAM STERILIZATION EQUIPMENT
K821591 · Getinge International, Inc. · Jun 1982
K833837 · AMERICAN GOLD SERIES AUTOCLAVE
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