Cleared Traditional

K883069 - MINIMON 7134B PATIENT MONITOR

K883069 is an FDA 510(k) clearance for MINIMON 7134B PATIENT MONITOR, manufactured by Kontron Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K883069 · Kontron Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1989
Decision
181d
Days
Class 2
Risk

K883069 is an FDA 510(k) clearance for the MINIMON 7134B PATIENT MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Kontron Instruments, Inc. (Everett, US). The FDA issued a Cleared decision on January 17, 1989 after a review of 181 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 Kontron Instruments, Inc. devices

FDA 510(k) Submission Details - K883069

510(k) Number K883069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1988
Decision Date January 17, 1989
Days to Decision 181 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
56d slower than avg
Panel avg: 125d · This submission: 181d
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 163
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K883069.
HORIZON CENTRAL STATION
K892066 · Mennen Medical, Inc. · Jun 1989
HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S
K892006 · Healthdyne, Inc. · May 1989
TYPE 9210 ECG SYSTEM ATHENA
K884117 · S & W Medico Teknik · Apr 1989
HEALTHDYNE APNEA/HEART MONITOR, MODEL 900
K874695 · Healthdyne, Inc. · Jan 1988
SERIES 2000 BEDSIDE PATIENT MONITOR
K872354 · Marquette Electronics, Inc. · Jul 1987
COMPANION 50 REGULATOR/FLOWMETER
K872443 · Puritan Bennett Corp. · Jul 1987