Cleared Traditional

K121578 - ATOM 1 (MODEL: BRC 2200)

K121578 is an FDA 510(k) clearance for ATOM 1 (MODEL: BRC 2200), manufactured by Bioelectric Research Corporation. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K121578 · Bioelectric Research Corporation · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
62d
Days
Class 2
Risk

K121578 is an FDA 510(k) clearance for the ATOM 1 (MODEL: BRC 2200). Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Bioelectric Research Corporation (Carson City, US). The FDA issued a Cleared decision on July 31, 2012 after a review of 62 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.

FDA 510(k) Submission Details - K121578

510(k) Number K121578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2012
Decision Date July 31, 2012
Days to Decision 62 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 149d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 451
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K121578.
STERLING MEDICAL IMPULSE 3 STIMULATOR
K121305 · Armstrong Industries, Inc. Dha Mediquip Int. Dha S · Sep 2012
WITOUCH PRO
K120398 · Hollywog, LLC · Aug 2012
SENSUS
K121184 · Neurometrix, Inc. · Aug 2012
ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER
K113544 · Prospera Corporation · Jul 2012
GEMORE TENS SYSTEM
K120569 · Gemore Technology Co, Ltd. · Jul 2012
ULTIMA NEO
K120054 · Pain Management Technologies · Jun 2012
K121578 · ATOM 1 (MODEL: BRC 2200)
Download PDF FDA Summary Bioelectric Research …