Cleared Traditional

K891107 - INDICATENS INDICATOR ELECTRODE MODEL 2

K891107 is an FDA 510(k) clearance for INDICATENS INDICATOR ELECTRODE MODEL 2, manufactured by Acudata Software. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K891107 · Acudata Software · Neurology device
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May 1989
Decision
84d
Days
Class 2
Risk

K891107 is an FDA 510(k) clearance for the INDICATENS INDICATOR ELECTRODE MODEL 2. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Acudata Software (Petaluma, US). The FDA issued a Cleared decision on May 25, 1989 after a review of 84 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 Acudata Software devices

FDA 510(k) Submission Details - K891107

510(k) Number K891107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1989
Decision Date May 25, 1989
Days to Decision 84 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 148d · This submission: 84d
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 318
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K891107.
PROMONTORY STIMULATING ELECTRODE
K895081 · Cadwell Laboratories, Inc. · Nov 1989
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K894042 · Labeltape Meditect, Inc. · Aug 1989
SPECT.E.N.S REPOSITIONABLE, SNAP-TYPE, TENS
K894043 · Labeltape Meditect, Inc. · Aug 1989
EMPI ISLAND TENS ELECTRODE
K890605 · Empi · Mar 1989
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K890614 · Empi · Mar 1989
EMPI REUSEABLE PIN-STYLE TENS ELECTRODE
K890747 · Empi · Mar 1989