Cleared Traditional

K152951 - Advanced Imaging Modality (AIM) Sterili...

K152951 is an FDA 510(k) clearance for Advanced Imaging Modality (AIM) Sterili..., manufactured by Paragon Medical, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K152951 · Paragon Medical, Inc. · General Hospital
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Dec 2015
Decision
83d
Days
Class 2
Risk

K152951 is an FDA 510(k) clearance for the Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Ster.... Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Paragon Medical, Inc. (Pierceton, US). The FDA issued a Cleared decision on December 28, 2015 after a review of 83 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 Paragon Medical, Inc. devices

FDA 510(k) Submission Details - K152951

510(k) Number K152951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2015
Decision Date December 28, 2015
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
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 K152951.
ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY
K152969 · Conmed Corporation · Mar 2016
Medtronic Transportation/Sterilization Cassettes
K152241 · Medtronic Sofamor Danek USA, Inc. · Jan 2016
Endoscope Sterilization Tray
K151450 · Intuitive Surgical, Inc. · Jan 2016
SterilContainer S
K151242 · Aesculap, Inc. · Oct 2015
NuVasive Sterilization Trays
K143579 · Nu Vasive, Incorporated · Aug 2015
SterilContainer S
K143729 · Aesculap, Inc. · Aug 2015