Cleared Traditional

K904462 - MODEL #210 STEALTH DEFIB PADS

K904462 is an FDA 510(k) clearance for MODEL #210 STEALTH DEFIB PADS, manufactured by Cardiotronics, Inc.. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K904462 · Cardiotronics, Inc. · Cardiovascular device
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Dec 1990
Decision
63d
Days
Class 2
Risk

K904462 is an FDA 510(k) clearance for the MODEL #210 STEALTH DEFIB PADS. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Cardiotronics, Inc. (West Carlsbad, US). The FDA issued a Cleared decision on December 3, 1990 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5300 - 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 - K904462

510(k) Number K904462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1990
Decision Date December 03, 1990
Days to Decision 63 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDD Device Classification - Class 2, Special Controls

Product Code LDD Dc-defibrillator, Low-energy, (including Paddles)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5300
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 - LDD Dc-defibrillator, Low-energy, (including Paddles)

All 81
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K904462.
SERIES 1500 RESPONDER
K902782 · Marquette Electronics, Inc. · Jan 1991
FIRST MEDIC MODEL 510
K896903 · Spacelabs, Inc. · Dec 1990
LIFEPAK 9 DEFIBRILLATOR & CARDIAC MONITOR/MODIFIED
K905510 · Physio-Control Corp. · Dec 1990
LIFEPAK 300 AUTOMATIC ADVISORY DEFIBRILLATOR
K902478 · Physio-Control Corp. · Oct 1990
THREADED PADDLE PAIRS, INTERNAL ADULT PEDI INFANT
K902590 · Marquette Electronics, Inc. · Jul 1990
LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)
K895379 · Physio-Control Corp. · Feb 1990