Cleared Traditional

K760972 - TYCOS DIAGNOSTIC PENLIGHT (FDA 510(k) Clearance)

Class I General Hospital device.

K760972 · Taylor Instrument Analytics Co. · General Hospital
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Jan 1977
Decision
83d
Days
Class 1
Risk

K760972 is an FDA 510(k) clearance for the TYCOS DIAGNOSTIC PENLIGHT. Classified as Light, Examination, Medical, Battery Powered (product code KYT), Class I - General Controls.

Submitted by Taylor Instrument Analytics Co. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1977 after a review of 83 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6350 - the FDA general hospital 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 Taylor Instrument Analytics Co. devices

Submission Details

510(k) Number K760972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1976
Decision Date January 26, 1977
Days to Decision 83 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 128d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYT Light, Examination, Medical, Battery Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6350
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.