Cleared Traditional

K874148 - MONITRON SYSTEM

K874148 is an FDA 510(k) clearance for MONITRON SYSTEM, manufactured by American Health Products, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K874148 · American Health Products, Inc. · Cardiovascular device
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Jun 1988
Decision
246d
Days
Class 2
Risk

K874148 is an FDA 510(k) clearance for the MONITRON SYSTEM. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by American Health Products, Inc. (Orange, US). The FDA issued a Cleared decision on June 15, 1988 after a review of 246 days - an extended review 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: 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 American Health Products, Inc. devices

FDA 510(k) Submission Details - K874148

510(k) Number K874148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1987
Decision Date June 15, 1988
Days to Decision 246 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 125d · This submission: 246d
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 175
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K874148.
MODEL 702 ECG/RESPIRATION/TEMPERATURE
K884455 · Ivy Biomedical Systems, Inc. · Mar 1989
PATIENT MONITOR MODEL 701
K884096 · Ivy Biomedical Systems, Inc. · Feb 1989
MINIMON 7134B PATIENT MONITOR
K883069 · Kontron Instruments, Inc. · Jan 1989
MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR
K880066 · Ivy Biomedical Systems, Inc. · Mar 1988
HEALTHDYNE APNEA/HEART MONITOR, MODEL 900
K874695 · Healthdyne, Inc. · Jan 1988
SERIES 2000 BEDSIDE PATIENT MONITOR
K872354 · Marquette Electronics, Inc. · Jul 1987