Cleared Traditional

K895081 - PROMONTORY STIMULATING ELECTRODE

K895081 is an FDA 510(k) clearance for PROMONTORY STIMULATING ELECTRODE, manufactured by Cadwell Laboratories, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K895081 · Cadwell Laboratories, Inc. · Neurology device
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Nov 1989
Decision
87d
Days
Class 2
Risk

K895081 is an FDA 510(k) clearance for the PROMONTORY STIMULATING ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Cadwell Laboratories, Inc. (Kennewick, US). The FDA issued a Cleared decision on November 9, 1989 after a review of 87 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 Cadwell Laboratories, Inc. devices

FDA 510(k) Submission Details - K895081

510(k) Number K895081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1989
Decision Date November 09, 1989
Days to Decision 87 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
61d faster than avg
Panel avg: 148d · This submission: 87d
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 210
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K895081.
L.A.S.P. LUMBAR AND SACRAL PAD, REPOSITION. SNAP
K896936 · Labeltape Meditect, Inc. · Jan 1990
MODIFIED ISLAND TENS DISP. ELECTRODE FOR SNAP CONN
K896485 · Empi · Dec 1989
TENZCARE ELECTRODE 6862
K893793 · 3M Company · Nov 1989
SPECT.E.N.S. REPOSITIONABLE, PIN TYPE, TENS
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