Cleared Traditional

K874695 - HEALTHDYNE APNEA/HEART MONITOR, MODEL 900

K874695 is an FDA 510(k) clearance for HEALTHDYNE APNEA/HEART MONITOR, manufactured by Healthdyne, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K874695 · Healthdyne, Inc. · Cardiovascular device
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Jan 1988
Decision
74d
Days
Class 2
Risk

K874695 is an FDA 510(k) clearance for the HEALTHDYNE APNEA/HEART MONITOR, MODEL 900. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Healthdyne, Inc. (Marietta, US). The FDA issued a Cleared decision on January 29, 1988 after a review of 74 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 Healthdyne, Inc. devices

FDA 510(k) Submission Details - K874695

510(k) Number K874695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1987
Decision Date January 29, 1988
Days to Decision 74 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
51d faster than avg
Panel avg: 125d · This submission: 74d
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 201
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K874695.
MINIMON 7134B PATIENT MONITOR
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K880498 · Ppg Industries, Inc. · May 1988
MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR
K880066 · Ivy Biomedical Systems, Inc. · Mar 1988
SERIES 2000 BEDSIDE PATIENT MONITOR
K872354 · Marquette Electronics, Inc. · Jul 1987
COMPANION 50 REGULATOR/FLOWMETER
K872443 · Puritan Bennett Corp. · Jul 1987
NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20
K863494 · Advantage Medical Systems, Inc. · Dec 1986