Cleared Traditional

K970182 - DINAMAP COMPACT MONITOR

K970182 is the FDA 510(k) clearance for DINAMAP COMPACT MONITOR by Johnson & Johnson Medical, Inc.. It is a Class 2 Cardiovascular device (product code MHX) cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K970182 · Johnson & Johnson Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
213d
Days
Class 2
Risk

K970182 is an FDA 510(k) clearance for the DINAMAP COMPACT MONITOR. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Johnson & Johnson Medical, Inc. (Tampa, US). The FDA issued a Cleared decision on August 18, 1997 after a review of 213 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Johnson & Johnson Medical, Inc. devices

Submission Details

510(k) Number K970182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1997
Decision Date August 18, 1997
Days to Decision 213 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 125d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 275
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K970182.
SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR
K993974 · Siemens Medical Solutions USA, Inc. · Feb 2000
SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM
K983996 · Spacelabs Medical, Inc. · Jun 1999
SIEMENS SC 8000 BEDSIDE MONITOR WITH ADVANCED COMMUNICATION OPTION
K990563 · Siemens Medical Solutions USA, Inc. · Mar 1999
DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340
K942700 · Critikon Company, LLC · Mar 1995
PORTABLE PATIENT MONITOR
K945134 · Hewlett-Packard Co. · Oct 1994
HEWLETT-PACKARD MODEL 78730 CAREVUE 5000
K922210 · Hewlett-Packard Co. · Apr 1993