Cleared Traditional

K152951 - Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Third Party Review Group, LLC
DAVE YUNGVIRT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 261
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K152951.
Ellipse Supplemental Instrument Trays
K151594 · Ellipse Technologies, Incorporated · Jan 2016
Medtronic Transportation/Sterilization Cassettes
K152241 · Medtronic Sofamor Danek USA, Inc. · Jan 2016
Endoscope Sterilization Tray
K151450 · Intuitive Surgical, Inc. · Jan 2016
INSTRUMENT CASSETTE (EFCCL1-F)
K141854 · Osung Mnd Co., Ltd. · Oct 2015
MTS300 Multiple Tray Sterilization System
K152014 · Pmbs, LLC · Oct 2015
MIS Spine Frame Instrument Case
K151347 · Thompson Surgical Instruments · Oct 2015

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.