Cleared Traditional

K821015 - CARE MODEL IP 4500 AUTO SCANNERR

K821015 is an FDA 510(k) clearance for CARE MODEL IP 4500 AUTO SCANNERR, manufactured by Care Monitoring Systems. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K821015 · Care Monitoring Systems · Cardiovascular device
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May 1982
Decision
42d
Days
Class 2
Risk

K821015 is an FDA 510(k) clearance for the CARE MODEL IP 4500 AUTO SCANNERR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Care Monitoring Systems (Mchenry, US). The FDA issued a Cleared decision on May 24, 1982 after a review of 42 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 Care Monitoring Systems devices

FDA 510(k) Submission Details - K821015

510(k) Number K821015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1982
Decision Date May 24, 1982
Days to Decision 42 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 125d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

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 229
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K821015.
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K821368 · Hewlett-Packard Co. · May 1982
CARDIAC MONITOR - RATE ALARM
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DIASCOPE 2
K820745 · Puritan Bennett Corp. · Apr 1982
#505 PORT. VITAL FUNCTIONS NEONATAL MON
K820416 · Ge Medical Systems Information Technologies · Mar 1982