Cleared Abbreviated

K190062 - STATCLAVE G4 Chamber Autoclave (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K190062 · Scican , Ltd. · General Hospital
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Jul 2019
Decision
192d
Days
Class 2
Risk

K190062 is an FDA 510(k) clearance for the STATCLAVE G4 Chamber Autoclave. 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 26, 2019 after a review of 192 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Scican , Ltd. devices

Submission Details

510(k) Number K190062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2019
Decision Date July 26, 2019
Days to Decision 192 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 128d · This submission: 192d
Pathway characteristics
Standards-based clearance path.

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 183
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