Cleared Traditional

K854198 - PE-3000 PULSE RATE MONITOR

K854198 is an FDA 510(k) clearance for PE-3000 PULSE RATE MONITOR, manufactured by Quantum Life Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K854198 · Quantum Life Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1986
Decision
149d
Days
Class 2
Risk

K854198 is an FDA 510(k) clearance for the PE-3000 PULSE RATE MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Quantum Life Systems, Inc. (Great Meadows, US). The FDA issued a Cleared decision on March 13, 1986 after a review of 149 days - within the typical 510(k) review window.

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 Quantum Life Systems, Inc. devices

FDA 510(k) Submission Details - K854198

510(k) Number K854198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1985
Decision Date March 13, 1986
Days to Decision 149 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 125d · This submission: 149d
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 228
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K854198.
ERG 555 COUCH ERGOMETER
K854493 · Robert Bosch Corp. · Jun 1986
CARDIOCAP MONITOR
K853953 · Instrumentarium Corp. · Jun 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
ECS 502
K840717 · Robert Bosch Corp. · Aug 1985