Cleared Traditional

K850749 - CONCEPT VIDEO IMAGING SYSTEM

K850749 is an FDA 510(k) clearance for CONCEPT VIDEO IMAGING SYSTEM, manufactured by Concept, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KQM cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K850749 · Concept, Inc. · General & Plastic Surgery device
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May 1985
Decision
84d
Days
Class 1
Risk

K850749 is an FDA 510(k) clearance for the CONCEPT VIDEO IMAGING SYSTEM. Classified as Camera, Surgical And Accessories (product code KQM), Class I - General Controls.

Submitted by Concept, Inc. (Clearwater, US). The FDA issued a Cleared decision on May 20, 1985 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4160 - the FDA general and plastic surgery 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 Concept, Inc. devices

FDA 510(k) Submission Details - K850749

510(k) Number K850749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1985
Decision Date May 20, 1985
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

KQM Device Classification - Class 1, General Controls

Product Code KQM Camera, Surgical And Accessories
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4160
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KQM Camera, Surgical And Accessories

Devices cleared under the same product code (KQM) and FDA review panel - the closest regulatory comparables to K850749.
ADAPTOR: KAPS CINE TO MOELLER BEAMSPLITTER
K900160 · Jedmed Instrument Co. · Jan 1990
VIDEO PRINTER, MODEL 3200
K860904 · Medline Industries, Inc. · Mar 1986
MED. DYNAMICS SATICAN VIDEO CAMERA 5410
K843294 · Medline Industries, Inc. · Dec 1984
MED. DYNAMICS HIGH RESOLUTION SOLID ST
K843295 · Medline Industries, Inc. · Dec 1984
GATOR DRAPES
K811717 · The Anspach Effort, Inc. · Jul 1981