Cleared Traditional

K910661 - MODEL 205 SHOCK-TRODE

K910661 is an FDA 510(k) clearance for MODEL 205 SHOCK-TRODE, manufactured by Cardiotronics, Inc.. The device is a Class 2 Cardiovascular device with product code DRO cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K910661 · Cardiotronics, Inc. · Cardiovascular device
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May 1991
Decision
78d
Days
Class 2
Risk

K910661 is an FDA 510(k) clearance for the MODEL 205 SHOCK-TRODE. Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Cardiotronics, Inc. (West Carlsbad, US). The FDA issued a Cleared decision on May 2, 1991 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5550 - 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 - K910661

510(k) Number K910661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1991
Decision Date May 02, 1991
Days to Decision 78 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
47d faster than avg
Panel avg: 125d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRO Device Classification - Class 2, Special Controls

Product Code DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5550
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 - DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)

All 30
Devices cleared under the same product code (DRO) and FDA review panel - the closest regulatory comparables to K910661.
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