Cleared Traditional

K162600 - Jewel Precision Reusable Rigid Steriliz...

K162600 is an FDA 510(k) clearance for Jewel Precision Reusable Rigid Steriliz..., manufactured by Jewel Precision Sheet Metal & Machine, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K162600 · Jewel Precision Sheet Metal & Machine, Inc. · General Hospital
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Dec 2016
Decision
81d
Days
Class 2
Risk

K162600 is an FDA 510(k) clearance for the Jewel Precision Reusable Rigid Sterilization Container System. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Jewel Precision Sheet Metal & Machine, Inc. (Cedar Park, US). The FDA issued a Cleared decision on December 9, 2016 after a review of 81 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Jewel Precision Sheet Metal & Machine, Inc. devices

FDA 510(k) Submission Details - K162600

510(k) Number K162600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2016
Decision Date December 09, 2016
Days to Decision 81 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 129d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 177
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K162600.
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SterilContainer S System
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Medtronic Transportation/Sterilization Cassettes
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Sterilization Tray
K160912 · STERIS Corporation · Oct 2016
Signia sterilization tray
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ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY
K152969 · Conmed Corporation · Mar 2016