Cleared Traditional

K821821 - PERCUTANEOUS TRACHEOSTOMY DEVICE

K821821 · Frederic J. Toye, M.D. · Gastroenterology & Urology device
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Jul 1982
Decision
27d
Days
-
Risk

K821821 is an FDA 510(k) clearance for the PERCUTANEOUS TRACHEOSTOMY DEVICE.

Submitted by Frederic J. Toye, M.D. (Walker, US). The FDA issued a Cleared decision on July 19, 1982 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology 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 Frederic J. Toye, M.D. devices

Submission Details

510(k) Number K821821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1982
Decision Date July 19, 1982
Days to Decision 27 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 130d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -