Cleared Traditional

MODEL 515 NEO-TRAK NEONATAL MONITOR (K823904) - FDA 510(k) Clearance

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

K823904 · Ge Medical Systems Information Technologies · Cardiovascular device
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May 1983
Decision
148d
Days
Class 2
Risk

K823904 is an FDA 510(k) clearance for the MODEL 515 NEO-TRAK NEONATAL MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Walker, US). The FDA issued a Cleared decision on May 25, 1983 after a review of 148 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Ge Medical Systems Information Technologies devices

Submission Details

510(k) Number K823904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1982
Decision Date May 25, 1983
Days to Decision 148 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
23d slower than avg
Panel avg: 125d · This submission: 148d
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 K823904.
PATIENT MONITOR 788 33A
K831943 · Hewlett-Packard Co. · Oct 1983
PATIENT MONITOR #78832A
K831944 · Hewlett-Packard Co. · Oct 1983
PATIENT MONITOR #78353A
K831787 · Hewlett-Packard Co. · Sep 1983
NEUROMEDICS PACETRON HEART RATE MONITOR
K823290 · Intermedics, Inc. · Dec 1982
MODEL 78534A PATIENT MONITOR
K822876 · Hewlett-Packard Co. · Oct 1982
SIGNAL DISTRIBUTION NETWORK #78581A
K822695 · Hewlett-Packard Co. · Oct 1982