Cleared Traditional

K854988 - KY-M280U SURGICAL CAMERA

K854988 is an FDA 510(k) clearance for KY-M280U SURGICAL CAMERA, manufactured by Us Jvc Corp.. The device is a Class 1 General & Plastic Surgery device with product code FWC cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K854988 · Us Jvc Corp. · General & Plastic Surgery device
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Jan 1986
Decision
43d
Days
Class 1
Risk

K854988 is an FDA 510(k) clearance for the KY-M280U SURGICAL CAMERA. Classified as Camera, Television, Surgical, With Audio (product code FWC), Class I - General Controls.

Submitted by Us Jvc Corp. (Elmwood Park, US). The FDA issued a Cleared decision on January 24, 1986 after a review of 43 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 Us Jvc Corp. devices

FDA 510(k) Submission Details - K854988

510(k) Number K854988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1985
Decision Date January 24, 1986
Days to Decision 43 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
72d faster than avg
Panel avg: 115d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

FWC Device Classification - Class 1, General Controls

Product Code FWC Camera, Television, Surgical, With Audio
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.