Cleared Traditional

ACUTE CARDIAC CARE SYSTEM (K772006) - FDA 510(k) Clearance

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

K772006 · Physio-Control Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1977
Decision
38d
Days
Class 2
Risk

K772006 is an FDA 510(k) clearance for the ACUTE CARDIAC CARE SYSTEM. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Physio-Control Corp. (Walker, US). The FDA issued a Cleared decision on November 28, 1977 after a review of 38 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 Physio-Control Corp. devices

Submission Details

510(k) Number K772006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1977
Decision Date November 28, 1977
Days to Decision 38 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 125d · This submission: 38d
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 74
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K772006.
MODEL 78801A PATIENT MONITORS
K790454 · Hewlett-Packard Co. · Apr 1979
ECG MONITORING SYSTEM,
K780404 · Quinton, Inc. · Mar 1978
MONITOR, CARDIAC, BEDSIDE
K772332 · Telectronics, Inc. · Feb 1978
PHYSIOLOGICAL MONITOR MODEL 871
K772056 · Datascope Corp. · Nov 1977
HEARTRATE METER MODEL 650, P/N 000119
K772097 · Quinton, Inc. · Nov 1977
LINE CHARGER MODEL LC-100
K772053 · Datascope Corp. · Nov 1977