Cleared Traditional

STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101 (K072466) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K072466 · Scican , Ltd. · General Hospital
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Dec 2007
Decision
106d
Days
Class 2
Risk

K072466 is an FDA 510(k) clearance for the STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT),.... Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Scican , Ltd. (Toronto, CA). The FDA issued a Cleared decision on December 19, 2007 after a review of 106 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 , Ltd. devices

Submission Details

510(k) Number K072466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2007
Decision Date December 19, 2007
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 62
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K072466.
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AMSCO EVOLUTION MEDIUM STEAM STERILIZER
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CLS-2000 UNIT
K024133 · Dentsply Intl. · Oct 2003
AMSCO CENTURY STEAM STERILIZER
K030789 · STERIS Corporation · Mar 2003
AMSCO CENTURY MEDIUM STERILIZER 26 X 26
K020747 · STERIS Corporation · May 2002