Cleared Traditional

K934051 - BIO SDP (AKA SATURN SD

K934051 is an FDA 510(k) clearance for BIO SDP (AKA SATURN SD, manufactured by Skylark Device Co., Ltd.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K934051 · Skylark Device Co., Ltd. · Neurology device
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Jul 1994
Decision
326d
Days
Class 2
Risk

K934051 is an FDA 510(k) clearance for the BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD). Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Skylark Device Co., Ltd. (Taiwan, R.O.C., TW). The FDA issued a Cleared decision on July 11, 1994 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. 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 Skylark Device Co., Ltd. devices

FDA 510(k) Submission Details - K934051

510(k) Number K934051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1993
Decision Date July 11, 1994
Days to Decision 326 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
178d slower than avg
Panel avg: 148d · This submission: 326d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 154
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K934051.
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K946299 · Skylark Device Co., Ltd. · Jun 1995
THERAPEUTIC ULTRASOUND AND STIMULATOR
K935324 · Chattanooga Group, Inc. · May 1994
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K935132 · Medical Devices, Inc. · Mar 1994
FLEXMATE
K934619 · Medical Devices, Inc. · Feb 1994