Cleared Traditional

K854317 - MINIPAC (TM)

K854317 is an FDA 510(k) clearance for MINIPAC (TM), manufactured by Medical Devices, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K854317 · Medical Devices, Inc. · Neurology device
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Jan 1986
Decision
85d
Days
Class 2
Risk

K854317 is an FDA 510(k) clearance for the MINIPAC (TM). Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Medical Devices, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 21, 1986 after a review of 85 days - a notably fast clearance cycle.

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: 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 Medical Devices, Inc. devices

FDA 510(k) Submission Details - K854317

510(k) Number K854317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1985
Decision Date January 21, 1986
Days to Decision 85 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 148d · This submission: 85d
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 140
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K854317.
FASTENS(TM)
K854316 · Medical Devices, Inc. · Feb 1986
VALLEY FORGE SCIEN-TENS UNIT & ACCESS. LEAD WIRE &
K853992 · Valley Forge Scientific Corp. · Feb 1986
MINIPAC PERSONAL TOUCH (TM)
K854761 · Medical Devices, Inc. · Feb 1986
SYS STIM 206 MODEL ME206
K851735 · Mettler Electronics Corp. · Nov 1985
TENSMED II
K851063 · Intermedics, Inc. · Jun 1985
ELECTRO-NERVE STIMULATOR DISCO B9 TENS
K851191 · Biomedical Life Systems, Inc. · May 1985