Cleared Traditional

PORTABLE CARDIAC MONITOR, ABBY (K760593) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K760593 · Abbott Laboratories · Cardiovascular device
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Sep 1976
Decision
9d
Days
Class 2
Risk

K760593 is an FDA 510(k) clearance for the PORTABLE CARDIAC MONITOR, ABBY. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 16, 1976 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Abbott Laboratories devices

Submission Details

510(k) Number K760593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1976
Decision Date September 16, 1976
Days to Decision 9 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
116d faster than avg
Panel avg: 125d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 69
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K760593.
CENTRAL STATION MONITORING SYSTEM
K761291 · Abbott Laboratories · Dec 1976
MODEL 15050A DIGITAL DISPLAY
K761211 · Hewlett-Packard Co. · Dec 1976
PHYSIOLOGICAL MONITOR (MODEL 870)
K760803 · Datascope Corp. · Oct 1976
MONITOR, PATIENT (MODEL 78333A)
K760160 · Hewlett-Packard Co. · Jul 1976