Cleared Special

K112872 - STATIM 2000 G4 CASSETTE

K112872 is an FDA 510(k) clearance for STATIM 2000 G4 CASSETTE, manufactured by Scican , Ltd.. The device is a Class 2 General Hospital device with product code FLE cleared through the Special 510(k) pathway after a 284-day FDA review.

K112872 · Scican , Ltd. · General Hospital
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Jul 2012
Decision
284d
Days
Class 2
Risk

K112872 is an FDA 510(k) clearance for the STATIM 2000 G4 CASSETTE. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Scican , Ltd. (Toronto, CA). The FDA issued a Cleared decision on July 10, 2012 after a review of 284 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Scican , Ltd. devices

FDA 510(k) Submission Details - K112872

510(k) Number K112872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2011
Decision Date July 10, 2012
Days to Decision 284 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 129d · This submission: 284d
Pathway characteristics
Modification to existing cleared device.

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 144
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