Cleared Traditional

LINQUAL-ORAL TRAINING SPLINT (K813603) - FDA 510(k) Clearance

K813603 · Charles F. Samelson, M.D. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1982
Decision
29d
Days
-
Risk

K813603 is an FDA 510(k) clearance for the LINQUAL-ORAL TRAINING SPLINT.

Submitted by Charles F. Samelson, M.D. (Walker, US). The FDA issued a Cleared decision on January 26, 1982 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel. 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 Charles F. Samelson, M.D. devices

Submission Details

510(k) Number K813603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1981
Decision Date January 26, 1982
Days to Decision 29 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -