Cleared Traditional

K960884 - TELE TRENS TM 10

K960884 is the FDA 510(k) clearance for TELE TRENS TM 10 by Life Sensing Instrument Company, Inc.. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 557-day FDA review.

K960884 · Life Sensing Instrument Company, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
557d
Days
Class 2
Risk

K960884 is an FDA 510(k) clearance for the TELE TRENS TM 10. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Life Sensing Instrument Company, Inc. (Tullahoma, US). The FDA issued a Cleared decision on September 12, 1997 after a review of 557 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Life Sensing Instrument Company, Inc. devices

Submission Details

510(k) Number K960884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1996
Decision Date September 12, 1997
Days to Decision 557 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
432d slower than avg
Panel avg: 125d · This submission: 557d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 229
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K960884.
SIEMENS MULTIVIEW WORKSTATION INFINITY TELEMETRY SYSTEM
K972714 · Siemens Medical Solutions USA, Inc. · Oct 1997
FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR
K971131 · Fukuda Denshi USA, Inc. · Oct 1997
SPACELABS MEDICAL PCIS PATIENT MONITORS
K972282 · Spacelabs Medical, Inc. · Sep 1997
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
K964624 · Siemens Medical Solutions USA, Inc. · Sep 1997
FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR
K970585 · Fukuda Denshi USA, Inc. · Sep 1997
SIEMENS SC/9000/SC9015 SERIES SURGICAL DISPLAY CONTROLLER
K970348 · Siemens Medical Solutions USA, Inc. · Aug 1997