Cleared Traditional

K101042 - BLADEVIEW

K101042 is an FDA 510(k) clearance for BLADEVIEW, manufactured by Accogent, LLC. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K101042 · Accogent, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
198d
Days
Class 2
Risk

K101042 is an FDA 510(k) clearance for the BLADEVIEW. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Accogent, LLC (Palm Beach, US). The FDA issued a Cleared decision on October 29, 2010 after a review of 198 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K101042

510(k) Number K101042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2010
Decision Date October 29, 2010
Days to Decision 198 days
Submission Type Traditional
Review Panel Radiology (RA)
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
91d slower than avg
Panel avg: 107d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 Radiology devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
MARK JOB

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 - KPR System, X-ray, Stationary

All 349
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K101042.
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K102680 · Control-X Medical, Inc. · Oct 2010
K101042 · BLADEVIEW
Download PDF FDA Summary Accogent, LLC