Cleared Traditional

K900160 - ADAPTOR: KAPS CINE TO MOELLER BEAMSPLITTER

K900160 is the FDA 510(k) clearance for ADAPTOR: KAPS CINE TO MOELLER BEAMSPLITTER by Jedmed Instrument Co.. It is a Class 1 General & Plastic Surgery device (product code KQM) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K900160 · Jedmed Instrument Co. · General & Plastic Surgery device
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Jan 1990
Decision
12d
Days
Class 1
Risk

K900160 is an FDA 510(k) clearance for the ADAPTOR: KAPS CINE TO MOELLER BEAMSPLITTER. Classified as Camera, Surgical And Accessories (product code KQM), Class I - General Controls.

Submitted by Jedmed Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on January 24, 1990 after a review of 12 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 Jedmed Instrument Co. devices

Submission Details

510(k) Number K900160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1990
Decision Date January 24, 1990
Days to Decision 12 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
103d faster than avg
Panel avg: 115d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

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