Cleared Traditional

OBSTETRICAL KIT (K863504) - FDA 510(k) Clearance

K863504 · Dyna-Med · Obstetrics & Gynecology device
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Oct 1986
Decision
43d
Days
-
Risk

K863504 is an FDA 510(k) clearance for the OBSTETRICAL KIT.

Submitted by Dyna-Med (Brewster, US). The FDA issued a Cleared decision on October 22, 1986 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology 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 K863504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received September 09, 1986
Decision Date October 22, 1986
Days to Decision 43 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 160d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -