Cleared Traditional

K882887 - PROGEL(TM)

K882887 is an FDA 510(k) clearance for PROGEL(TM), manufactured by Medical Devices, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K882887 · Medical Devices, Inc. · Neurology device
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Sep 1988
Decision
80d
Days
Class 2
Risk

K882887 is an FDA 510(k) clearance for the PROGEL(TM), MODELS 8630 AND 8635. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Medical Devices, Inc. (St. Paul, US). The FDA issued a Cleared decision on September 29, 1988 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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 - K882887

510(k) Number K882887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1988
Decision Date September 29, 1988
Days to Decision 80 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
68d faster than avg
Panel avg: 148d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 157
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K882887.
MODIFIED JELTRODE(TM) ELECTRODES DEEMED
K884348 · Henley Intl. · Dec 1988
MULTIDAY, MODELS 8300 AND 8310
K882888 · Medical Devices, Inc. · Sep 1988
PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535
K882886 · Medical Devices, Inc. · Sep 1988
STRAIGHT-LINE FINISH FOR IMPLANTABLE PULSE GENERA.
K881749 · Medtronic Vascular · Jul 1988
SPARE MS 700 TENS ELECTRODE
K881871 · Lectec Corp. · Jun 1988
TENS ELECTRODE MODEL 238P
K881872 · Lectec Corp. · Jun 1988