Cleared Traditional

K864754 - BECKER EXTERNAL DRAINAGE & MONITOR SYSTEM TROCAR (FDA 510(k) Clearance)

K864754 · Pudenz-Schulte Medical Research Corp. · Neurology device
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Dec 1986
Decision
17d
Days
-
Risk

K864754 is an FDA 510(k) clearance for the BECKER EXTERNAL DRAINAGE & MONITOR SYSTEM TROCAR.

Submitted by Pudenz-Schulte Medical Research Corp. (Goleta, US). The FDA issued a Cleared decision on December 22, 1986 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Neurology 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 Pudenz-Schulte Medical Research Corp. devices

Submission Details

510(k) Number K864754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1986
Decision Date December 22, 1986
Days to Decision 17 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d faster than avg
Panel avg: 148d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -