Cleared Special

ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR (K992413) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K992413 · Medical Data Electronics · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 70
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K992413.
TRANSMITTER, ZS-940PA SERIES
K043517 · Nihon Kohden America, Inc. · Feb 2005
PM-8000 PATIENT MONITOR, MODEL 8000
K032733 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2004
SIEMENS INFINITY SC 6002XL MODIFICATIONS
K020144 · Siemens Medical Solutions USA, Inc. · Feb 2002
ATLAS MONITOR
K984033 · Welch Allyn, Inc. · Jul 1999
PASSPORT 5L-CE MODEL 0998-00-0131XXX
K974178 · Datascope Corp. · Jun 1998
NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES
K973918 · Nihon Kohden America, Inc. · Jan 1998