Cleared Traditional

K202861 - Needle Stimulator

K202861 · Wuxi Jiajian Medical Instrument Co., Ltd. · Neurology device
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Aug 2021
Decision
333d
Days
-
Risk

K202861 is an FDA 510(k) clearance for the Needle Stimulator. Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Wuxi Jiajian Medical Instrument Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on August 27, 2021 after a review of 333 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Wuxi Jiajian Medical Instrument Co., Ltd. devices

FDA 510(k) Submission Details - K202861

510(k) Number K202861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2020
Decision Date August 27, 2021
Days to Decision 333 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
185d slower than avg
Panel avg: 148d · This submission: 333d
Pathway characteristics
Predicate-based equivalence.

BWK Device Classification - Class 0,

Product Code BWK Stimulator, Electro-acupuncture
Device Class -