Cleared Traditional

K910241 - STATIM CASSETTE AUTOCLAVE

K910241 is an FDA 510(k) clearance for STATIM 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 101-day FDA review.

K910241 · Scican · General Hospital
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May 1991
Decision
101d
Days
Class 2
Risk

K910241 is an FDA 510(k) clearance for the STATIM CASSETTE AUTOCLAVE. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Scican (Toronto, Ontario, CA). The FDA issued a Cleared decision on May 3, 1991 after a review of 101 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K910241

510(k) Number K910241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1991
Decision Date May 03, 1991
Days to Decision 101 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
28d faster than avg
Panel avg: 129d · This submission: 101d
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 171
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K910241.
STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS)
K910778 · Mdt Biologic Co. · Oct 1991
KAVOKLAVE STEAM AUTOCLAVE
K910789 · Kavo America · Aug 1991
MODEL #M9 ULTRACLAVE STEAM STERILIZER
K911322 · Midmark Corp. · Aug 1991
HARVARD/LTE LABORATORY STEAM STERILIZER AUTOCLAVE
K903614 · Harvard Apparatus, Inc. · Dec 1990
JOSLYN STEAM STERILIZER / STEAM MODERNIZATION KIT
K901147 · Joslyn Valve Corp. · Nov 1990
MAC LAVE STEAM STERILIZER
K895275 · Merchants Export Development Corp. · Nov 1990
K910241 · STATIM CASSETTE AUTOCLAVE
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