Cleared Traditional

K921613 - STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510

K921613 is an FDA 510(k) clearance for STERILIZER, manufactured by Dept. of the Army. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K921613 · Dept. of the Army · General Hospital
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Jan 1993
Decision
298d
Days
Class 2
Risk

K921613 is an FDA 510(k) clearance for the STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Dept. of the Army (Falls Church, US). The FDA issued a Cleared decision on January 29, 1993 after a review of 298 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 Dept. of the Army devices

FDA 510(k) Submission Details - K921613

510(k) Number K921613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1992
Decision Date January 29, 1993
Days to Decision 298 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
169d slower than avg
Panel avg: 129d · This submission: 298d
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 121
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K921613.
EASTERCLAVE
K961230 · Easter Services, Inc. · Jun 1996
MIDMARK M-11 ULTRACLAVE STEAM STERILIZER
K936181 · Midmark Corp. · Nov 1994
MDT/HARVEY MC-8 AND MC-10
K924955 · Mdt Corp., Inc. · Oct 1993
EAGLE 3000 SDS
K912471 · Amsco Co. · Jun 1992
DAVIS AND GECK HANDHELD INST. STERILIZATION TRAY
K920293 · Davis & Geck, Inc. · Apr 1992
KAVOKLAVE STEAM AUTOCLAVE
K910789 · Kavo America · Aug 1991