Cleared Traditional

K120752 - AERODR STITCHING SYSTEM

K120752 is an FDA 510(k) clearance for AERODR STITCHING SYSTEM, manufactured by Konica Minolta Medical & Graphic, Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K120752 · Konica Minolta Medical & Graphic, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
88d
Days
Class 2
Risk

K120752 is an FDA 510(k) clearance for the AERODR STITCHING SYSTEM. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Konica Minolta Medical & Graphic, Inc. (New York, US). The FDA issued a Cleared decision on June 8, 2012 after a review of 88 days - a notably fast clearance 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: 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 Konica Minolta Medical & Graphic, Inc. devices

FDA 510(k) Submission Details - K120752

510(k) Number K120752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2012
Decision Date June 08, 2012
Days to Decision 88 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 107d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - KPR System, X-ray, Stationary

All 183
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K120752.
XGEO GU60
K123105 · Samsung Electronics Co., Ltd. · Jun 2013
XGEO GC80
K123098 · Samsung Electronics Co., Ltd. · Jan 2013
FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION
K122454 · Fujifilm Medical System U.S.A., Inc. · Nov 2012
AERODR X70
K121109 · Konica Minolta Medical & Graphic, Inc. · May 2012
AERODR SYSTEM WITH P-21
K113248 · Konica Minolta Medical & Graphic, Inc. · Jan 2012
DX-D 600
K112670 · Agfa Healthcare N.V. · Oct 2011