Cleared Traditional

K021064 - QUANTIM 16 AUTOCLAVE

K021064 is an FDA 510(k) clearance for QUANTIM 16 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 128-day FDA review.

K021064 · Scican · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
128d
Days
Class 2
Risk

K021064 is an FDA 510(k) clearance for the QUANTIM 16 AUTOCLAVE. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Scican (Toronto, CA). The FDA issued a Cleared decision on August 8, 2002 after a review of 128 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.

View all Scican devices

FDA 510(k) Submission Details - K021064

510(k) Number K021064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2002
Decision Date August 08, 2002
Days to Decision 128 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 129d · This submission: 128d
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 106
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K021064.
AMSCO CENTURY STEAM STERILIZER
K030789 · STERIS Corporation · Mar 2003
MIDMARK M9 ULTRACLAVE STEAM STERILIZER
K023348 · Midmark Corp. · Mar 2003
W & H LISA STEAM STERILIZER
K022816 · A-Dec, Inc. · Feb 2003
AMSCO CENTURY MEDIUM STERILIZER 26 X 26
K020747 · STERIS Corporation · May 2002
AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY
K010865 · STERIS Corporation · May 2001
TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP
K993856 · Tuttnauer U.S.A Co, Ltd. · Feb 2001