Cleared Traditional

K791001 - PENLIGHT/SWAB HOLDER (FDA 510(k) Clearance)

Class I General Hospital device.

K791001 · Concept, Inc. · General Hospital
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Jun 1979
Decision
24d
Days
Class 1
Risk

K791001 is an FDA 510(k) clearance for the PENLIGHT/SWAB HOLDER. Classified as Light, Examination, Medical, Battery Powered (product code KYT), Class I - General Controls.

Submitted by Concept, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1979 after a review of 24 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 Concept, Inc. devices

Submission Details

510(k) Number K791001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1979
Decision Date June 22, 1979
Days to Decision 24 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
104d faster than avg
Panel avg: 128d · This submission: 24d
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.