Cleared Traditional

K913226 - MODEL #810 STEALTH-STIM ADULT STIMULATI...

K913226 is an FDA 510(k) clearance for MODEL #810 STEALTH-STIM ADULT STIMULATI..., manufactured by Cardiotronics, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K913226 · Cardiotronics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1991
Decision
47d
Days
Class 2
Risk

K913226 is an FDA 510(k) clearance for the MODEL #810 STEALTH-STIM ADULT STIMULATION PADS. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Cardiotronics, Inc. (West Carlsbad, US). The FDA issued a Cleared decision on September 4, 1991 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - the FDA cardiovascular device oversight 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 Cardiotronics, Inc. devices

FDA 510(k) Submission Details - K913226

510(k) Number K913226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1991
Decision Date September 04, 1991
Days to Decision 47 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 125d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DRX Electrode, Electrocardiograph

All 92
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K913226.
TRACET T-6000
K930258 · Lectec Corp. · Apr 1993
MODEL 1300 SOFTRACE II ELECTRODE
K921164 · Medtronic Vascular · Mar 1993
ECG ELECTRODE
K923558 · Lectec Corp. · Feb 1993
TRACETS SME 5000
K912450 · Lectec Corp. · Aug 1991
TRACET AG 4000
K904512 · Lectec Corp. · Jan 1991
MODEL 1850 ELECTRODE
K903918 · Medtronic Vascular · Oct 1990