Cleared Traditional

K890359 - RESUBMITTED STC SERIES 8600 AUTOCLAVE

K890359 is an FDA 510(k) clearance for RESUBMITTED STC SERIES 8600 AUTOCLAVE, manufactured by Sterilizer Technologies Corp.. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K890359 · Sterilizer Technologies Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1989
Decision
194d
Days
Class 2
Risk

K890359 is an FDA 510(k) clearance for the RESUBMITTED STC SERIES 8600 AUTOCLAVE. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Sterilizer Technologies Corp. (Greensboro, US). The FDA issued a Cleared decision on August 7, 1989 after a review of 194 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 Sterilizer Technologies Corp. devices

FDA 510(k) Submission Details - K890359

510(k) Number K890359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1989
Decision Date August 07, 1989
Days to Decision 194 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
65d slower than avg
Panel avg: 129d · This submission: 194d
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 137
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K890359.
MODEL #M8 ELECTRONIC STERILIZER
K900432 · Midmark Corp. · Jul 1990
PRESSURE STEAM STERILIZERS
K895848 · Scientific Device Laboratory, Inc. · Dec 1989
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