Cleared Traditional

K863534 - LIFE-WATCH MONITOR LT-8

K863534 is an FDA 510(k) clearance for LIFE-WATCH MONITOR LT-8, manufactured by Computerized Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K863534 · Computerized Medical Systems, Inc. · Cardiovascular device
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Nov 1986
Decision
71d
Days
Class 2
Risk

K863534 is an FDA 510(k) clearance for the LIFE-WATCH MONITOR LT-8. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Computerized Medical Systems, Inc. (Northbrook, US). The FDA issued a Cleared decision on November 21, 1986 after a review of 71 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Computerized Medical Systems, Inc. devices

FDA 510(k) Submission Details - K863534

510(k) Number K863534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1986
Decision Date November 21, 1986
Days to Decision 71 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 125d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 168
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K863534.
SERIES 2000 BEDSIDE PATIENT MONITOR
K872354 · Marquette Electronics, Inc. · Jul 1987
COMPANION 50 REGULATOR/FLOWMETER
K872443 · Puritan Bennett Corp. · Jul 1987
LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC
K862463 · Nihon Kohden America, Inc. · Dec 1986
PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM
K855125 · Honeywell, Inc. · Mar 1986
PATIENT MONITOR PB240
K853318 · Puritan Bennett Corp. · Mar 1986
SIRECUST 341 AND 341R
K854881 · Siemens Medical Solutions USA, Inc. · Mar 1986