Cleared Traditional

BLADE, TONGUE (K811157) - FDA 510(k) Clearance

K811157 · Dyn-A-Med Products · General & Plastic Surgery device
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May 1981
Decision
29d
Days
-
Risk

K811157 is an FDA 510(k) clearance for the BLADE, TONGUE.

Submitted by Dyn-A-Med Products (Mchenry, US). The FDA issued a Cleared decision on May 27, 1981 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery 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.

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Submission Details

510(k) Number K811157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1981
Decision Date May 27, 1981
Days to Decision 29 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -