Cleared Traditional

K972880 - MDP2000 MEDICAL DATA PROCESSOR

K972880 is an FDA 510(k) clearance for MDP2000 MEDICAL DATA PROCESSOR, manufactured by Vidco, Inc.. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K972880 · Vidco, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
78d
Days
Class 2
Risk

K972880 is an FDA 510(k) clearance for the MDP2000 MEDICAL DATA PROCESSOR. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Vidco, Inc. (Beaverton, US). The FDA issued a Cleared decision on October 22, 1997 after a review of 78 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 Vidco, Inc. devices

FDA 510(k) Submission Details - K972880

510(k) Number K972880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1997
Decision Date October 22, 1997
Days to Decision 78 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
47d faster than avg
Panel avg: 125d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSX Device Classification - Class 2, Special Controls

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 101
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K972880.
IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM
K971868 · Marquette Electronics, Inc. · Nov 1997
(VCOM, IRVS, RVS) CENTRAL MONITORING STATION, V-LINK OR AMBULATORY TRANSMITTERS AND ARRHYTMIA DETECTOR AND ALARMS WITH
K962473 · Data Critical Corporation · Nov 1997
WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET
K971683 · Marquette Electronics, Inc. · Oct 1997
DINAMAP MPS PORTABLE MONITOR
K971569 · Johnson & Johnson Medical, Inc. · Sep 1997