Cleared Special

K992413 - ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR

K992413 is an FDA 510(k) clearance for ESCORT 100/300 SERIES B (ESCORT II) PAT..., manufactured by Medical Data Electronics. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Special 510(k) pathway after a 30-day FDA review.

K992413 · Medical Data Electronics · Cardiovascular device
Download Printable Device Report (PDF)
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Aug 1999
Decision
30d
Days
Class 2
Risk

K992413 is an FDA 510(k) clearance for the ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on August 19, 1999 after a review of 30 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. 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 - K992413

510(k) Number K992413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1999
Decision Date August 19, 1999
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 229
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K992413.
A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR
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MICROPAQ, MODELS 402 AND 404
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K992411 · Medical Data Electronics · Aug 1999
ATLAS MONITOR
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DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1
K981378 · Datex-Engstrom, Inc. · Nov 1998