Cleared Special

K000660 - ESCORT II+ 400 SERIES (ESCORT PRISM)

K000660 is an FDA 510(k) clearance for ESCORT II+ 400 SERIES (ESCORT PRISM), manufactured by Medical Data Electronics. The device is a Class 2 Cardiovascular device with product code DRO cleared through the Special 510(k) pathway after a 29-day FDA review.

K000660 · Medical Data Electronics · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
29d
Days
Class 2
Risk

K000660 is an FDA 510(k) clearance for the ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MOD.... Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on March 28, 2000 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5550 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medical Data Electronics devices

FDA 510(k) Submission Details - K000660

510(k) Number K000660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2000
Decision Date March 28, 2000
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

DRO Device Classification - Class 2, Special Controls

Product Code DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5550
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 - DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)

All 36
Devices cleared under the same product code (DRO) and FDA review panel - the closest regulatory comparables to K000660.
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
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CARDIOSERV P
K962547 · Marquette Electronics, Inc. · Mar 1997
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K963120 · Marquette Electronics, Inc. · Feb 1997
ESORT II + 400 SERIES MONITOR
K961138 · Medical Data Electronics · Dec 1996
ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000
K950856 · Zoll Medical Corp · Dec 1995
LIFEPAK 11
K951593 · Physio-Control Corp. · Dec 1995