Cleared Traditional

MONITOR, NEONATE, MODEL 78213A (K770023) - FDA 510(k) Clearance

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

K770023 · Hewlett-Packard Co. · Cardiovascular device
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Feb 1977
Decision
53d
Days
Class 2
Risk

K770023 is an FDA 510(k) clearance for the MONITOR, NEONATE, MODEL 78213A. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Mchenry, US). The FDA issued a Cleared decision on February 28, 1977 after a review of 53 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K770023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1977
Decision Date February 28, 1977
Days to Decision 53 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
72d faster than avg
Panel avg: 125d · This submission: 53d
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 54
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K770023.
HEARTRATE METER MODEL 650, P/N 000119
K772097 · Quinton, Inc. · Nov 1977
ECG SCOPE MODEL 7833
K771360 · Hewlett-Packard Co. · Aug 1977
MONITOR, NEONATAL, MODEL 78261A
K770022 · Hewlett-Packard Co. · Feb 1977
MONITOR, NEONATAL, MODEL 78260A
K770024 · Hewlett-Packard Co. · Feb 1977
MONITOR, HEARTWATCH HEART RATE
K770038 · Respironics, Inc. · Jan 1977
CENTRAL STATION MONITORING SYSTEM
K761291 · Abbott Laboratories · Dec 1976