Cleared Abbreviated

K172292 - SALUS - Hygiene Instrument Reprocessing...

K172292 is an FDA 510(k) clearance for SALUS - Hygiene Instrument Reprocessing..., manufactured by Scican , Ltd.. The device is a Class 2 General Hospital device with product code KCT cleared through the Abbreviated 510(k) pathway after a 116-day FDA review.

K172292 · Scican , Ltd. · General Hospital
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Nov 2017
Decision
116d
Days
Class 2
Risk

K172292 is an FDA 510(k) clearance for the SALUS - Hygiene Instrument Reprocessing Container. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Scican , Ltd. (Toronto, CA). The FDA issued a Cleared decision on November 24, 2017 after a review of 116 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - 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

FDA 510(k) Submission Details - K172292

510(k) Number K172292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2017
Decision Date November 24, 2017
Days to Decision 116 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
13d faster than avg
Panel avg: 129d · This submission: 116d
Pathway characteristics
Standards-based clearance path.

KCT Device Classification - Class 2, Special Controls

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 173
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