Cleared Traditional

K873419 - VIDEO PRINTER SYSTEM

K873419 is an FDA 510(k) clearance for VIDEO PRINTER SYSTEM, manufactured by Technology For Imaging, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KQM cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K873419 · Technology For Imaging, Inc. · General & Plastic Surgery device
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Nov 1987
Decision
68d
Days
Class 1
Risk

K873419 is an FDA 510(k) clearance for the VIDEO PRINTER SYSTEM. Classified as Camera, Surgical And Accessories (product code KQM), Class I - General Controls.

Submitted by Technology For Imaging, Inc. (Ashland, US). The FDA issued a Cleared decision on November 2, 1987 after a review of 68 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 Technology For Imaging, Inc. devices

FDA 510(k) Submission Details - K873419

510(k) Number K873419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1987
Decision Date November 02, 1987
Days to Decision 68 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 115d · This submission: 68d
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 K873419.
ADAPTOR: KAPS CINE TO MOELLER BEAMSPLITTER
K900160 · Jedmed Instrument Co. · Jan 1990
VIDEO PRINTER, MODEL 3200
K860904 · Medline Industries, Inc. · Mar 1986
CONCEPT VIDEO IMAGING SYSTEM
K850749 · Concept, Inc. · May 1985
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