Cleared Traditional

K921606 - MODEL #125 CHILD STIMULATION PADS

K921606 is an FDA 510(k) clearance for MODEL #125 CHILD STIMULATION 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 53-day FDA review.

K921606 · Cardiotronics, Inc. · Cardiovascular device
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May 1992
Decision
53d
Days
Class 2
Risk

K921606 is an FDA 510(k) clearance for the MODEL #125 CHILD STIMULATION 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 May 26, 1992 after a review of 53 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 - K921606

510(k) Number K921606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1992
Decision Date May 26, 1992
Days to Decision 53 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
72d faster than avg
Panel avg: 125d · This submission: 53d
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 K921606.
MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE)
K922172 · Cardiotronics, Inc. · Jun 1992
MODEL # 830 ST ADULT STIMULATION PADS (STERILE)
K922173 · Cardiotronics, Inc. · Jun 1992
MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE
K922227 · Cardiotronics, Inc. · Jun 1992
PEDIATRIC DISPOSABLE EXTERNAL DEFIBRILATION/ECG
K912966 · Physio-Control Corp. · Feb 1992
SHOCK-PATCH ADULT DEFIBRILLATION PADS
K920086 · Cardiotronics, Inc. · Feb 1992
ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION
K914458 · Medical Data Electronics · Dec 1991