Cleared Traditional

K912283 - DETACHABLE

K912283 is an FDA 510(k) clearance for DETACHABLE, manufactured by Chalgren Enterprises, Inc.. The device is a Class 2 Neurology device with product code IKT cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K912283 · Chalgren Enterprises, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
298d
Days
Class 2
Risk

K912283 is an FDA 510(k) clearance for the DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE. Classified as Electrode, Needle, Diagnostic Electromyograph (product code IKT), Class II - Special Controls.

Submitted by Chalgren Enterprises, Inc. (Gilroy, US). The FDA issued a Cleared decision on March 16, 1992 after a review of 298 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1385 - 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. Standard predicate reliance. 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 Chalgren Enterprises, Inc. devices

FDA 510(k) Submission Details - K912283

510(k) Number K912283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1991
Decision Date March 16, 1992
Days to Decision 298 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 148d · This submission: 298d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKT Device Classification - Class 2, Special Controls

Product Code IKT Electrode, Needle, Diagnostic Electromyograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1385
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 - IKT Electrode, Needle, Diagnostic Electromyograph

All 17
Devices cleared under the same product code (IKT) and FDA review panel - the closest regulatory comparables to K912283.
DANTEC DISPOSABLE CONCENTRIC NEEDLE
K931966 · Dantec Medical, Inc. · Mar 1994
DISPOSABLE CONCENTRIC NEEDLE ELECTRODE
K924521 · Chalgren Enterprises, Inc. · Feb 1993
DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS
K912282 · Chalgren Enterprises, Inc. · Mar 1992
DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12
K896874 · Dantec Medical, Inc. · Jun 1990
EMG ELECTRODES AND EXTENSION CORDS
K870795 · Nihon Kohden America, Inc. · Mar 1987
MEB-5200
K854664 · Nihon Kohden America, Inc. · Aug 1986