Cleared Traditional

K962179 - STAT IM 5000 CASSETTE AUTOCLAVE

K962179 is an FDA 510(k) clearance for STAT IM 5000 CASSETTE AUTOCLAVE, manufactured by Scican. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K962179 · Scican · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
221d
Days
Class 2
Risk

K962179 is an FDA 510(k) clearance for the STAT IM 5000 CASSETTE AUTOCLAVE. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Scican (Pittsburgh, US). The FDA issued a Cleared decision on January 13, 1997 after a review of 221 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 Scican devices

FDA 510(k) Submission Details - K962179

510(k) Number K962179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1996
Decision Date January 13, 1997
Days to Decision 221 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 129d · This submission: 221d
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 105
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K962179.
STRYKER ENCORE STERILIZER
K962755 · Stryker Corp. · Mar 1997
DELTA
K945117 · Pelton & Crane Co. · Feb 1997
STERILEMAX
K953938 · Barnstead/Thermolyne Corp. · Jan 1997
STERIMASTER AUTOCLAVE
K944036 · Scican · Oct 1996
ACCESS (POWERCLAVE)
K954736 · Mdt Biologic Co. · Aug 1996
EASTERCLAVE
K961230 · Easter Services, Inc. · Jun 1996