Cleared Traditional

K971569 - DINAMAP MPS PORTABLE MONITOR

K971569 is the FDA 510(k) clearance for DINAMAP MPS PORTABLE MONITOR by Johnson & Johnson Medical, Inc.. It is a Class 2 Cardiovascular device (product code MSX) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K971569 · Johnson & Johnson Medical, Inc. · Cardiovascular device
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Sep 1997
Decision
143d
Days
Class 2
Risk

K971569 is an FDA 510(k) clearance for the DINAMAP MPS PORTABLE MONITOR. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Johnson & Johnson Medical, Inc. (Tampa, US). The FDA issued a Cleared decision on September 19, 1997 after a review of 143 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 Johnson & Johnson Medical, Inc. devices

Submission Details

510(k) Number K971569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1997
Decision Date September 19, 1997
Days to Decision 143 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
18d slower than avg
Panel avg: 125d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MSX System, Network And Communication, Physiological Monitors
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 - MSX System, Network And Communication, Physiological Monitors

All 69
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K971569.
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K971868 · Marquette Electronics, Inc. · Nov 1997
WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET
K971683 · Marquette Electronics, Inc. · Oct 1997