Cleared Traditional

K781973 - CARDIOPHONE

K781973 is an FDA 510(k) clearance for CARDIOPHONE, manufactured by North American Motronic. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K781973 · North American Motronic · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1979
Decision
114d
Days
Class 3
Risk

K781973 is an FDA 510(k) clearance for the CARDIOPHONE. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by North American Motronic (Mchenry, US). The FDA issued a Cleared decision on March 21, 1979 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3610 - 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: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all North American Motronic devices

FDA 510(k) Submission Details - K781973

510(k) Number K781973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1978
Decision Date March 21, 1979
Days to Decision 114 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 125d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

DXY Device Classification - Class 3, Premarket Approval

Product Code DXY Implantable Pacemaker Pulse-generator
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3610
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DXY Implantable Pacemaker Pulse-generator

All 394
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K781973.
OMNI-STANICOR-(THETA) MODEL 217
K790690 · Cordis Corp. · May 1979
PULSE GENERATOR MODEL 61 AND 128
K790562 · Ela Medical, Inc. · May 1979
PACEMAKERS WITHOUT SILASTIC COATING
K790764 · Telectronics, Inc. · Apr 1979
MICROLITH MODELS 505
K790432 · Cardiac Pacemakers, Inc. · Mar 1979
MINILITH AND MICROLITH
K790276 · Cardiac Pacemakers, Inc. · Feb 1979
PULSE GENERATOR, IMPLANTABLE CARDIAC
K782149 · Telectronics, Inc. · Feb 1979