Cleared Traditional

HALOGEN EXAM. LITE #48400 (K780628) - FDA 510(k) Clearance

Class I General Hospital device.

K780628 · Welch Allyn, Inc. · General Hospital
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Jun 1978
Decision
50d
Days
Class 1
Risk

K780628 is an FDA 510(k) clearance for the HALOGEN EXAM. LITE #48400. Classified as Device, Medical Examination, Ac Powered (product code KZF), Class I - General Controls.

Submitted by Welch Allyn, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 6, 1978 after a review of 50 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6320 - 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 Welch Allyn, Inc. devices

Submission Details

510(k) Number K780628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1978
Decision Date June 06, 1978
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KZF Device, Medical Examination, Ac Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6320
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.