Cleared Traditional

K840353 - PACEMAKER PULSE GENERATOR W/ELECTRODE

K840353 is an FDA 510(k) clearance for PACEMAKER PULSE GENERATOR W/ELECTRODE, manufactured by Ross Research, Inc.. The device is a Class 2 Cardiovascular device with product code DRO cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K840353 · Ross Research, Inc. · Cardiovascular device
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Apr 1984
Decision
88d
Days
Class 2
Risk

K840353 is an FDA 510(k) clearance for the PACEMAKER PULSE GENERATOR W/ELECTRODE. Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Ross Research, Inc. (Walker, US). The FDA issued a Cleared decision on April 23, 1984 after a review of 88 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 Ross Research, Inc. devices

FDA 510(k) Submission Details - K840353

510(k) Number K840353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1984
Decision Date April 23, 1984
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
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 58
Devices cleared under the same product code (DRO) and FDA review panel - the closest regulatory comparables to K840353.
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