Cleared Traditional

K140788 - P-STIM

K140788 · Biegler GmbH · Neurology device
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Jun 2014
Decision
88d
Days
-
Risk

K140788 is an FDA 510(k) clearance for the P-STIM. Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Biegler GmbH (Bonita Springs, US). The FDA issued a Cleared decision on June 27, 2014 after a review of 88 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.

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FDA 510(k) Submission Details - K140788

510(k) Number K140788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2014
Decision Date June 27, 2014
Days to Decision 88 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 148d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

BWK Device Classification - Class 0,

Product Code BWK Stimulator, Electro-acupuncture
Device Class -