Cleared Traditional

DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1 (K981378) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K981378 · Datex-Engstrom, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
201d
Days
Class 2
Risk

K981378 is an FDA 510(k) clearance for the DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Datex-Engstrom, Inc. (Tewksburt, US). The FDA issued a Cleared decision on November 3, 1998 after a review of 201 days - an extended review 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: 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 Datex-Engstrom, Inc. devices

Submission Details

510(k) Number K981378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1998
Decision Date November 03, 1998
Days to Decision 201 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 125d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 74
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K981378.
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
HEWLETT-PACKARD CARDIAC CATHETERIZATION RECORDING
K921194 · Hewlett-Packard Co. · Nov 1992