Cleared Traditional

K894919 - NR5000 E.C.G. AND PULSE OXIMETER MONITOR

K894919 is an FDA 510(k) clearance for NR5000 E.C.G. AND PULSE OXIMETER MONITOR, manufactured by Nirad , Ltd.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K894919 · Nirad , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1989
Decision
47d
Days
Class 2
Risk

K894919 is an FDA 510(k) clearance for the NR5000 E.C.G. AND PULSE OXIMETER MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Nirad , Ltd. (Antrim Co. Antrim, IE). The FDA issued a Cleared decision on September 18, 1989 after a review of 47 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 Nirad , Ltd. devices

FDA 510(k) Submission Details - K894919

510(k) Number K894919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1989
Decision Date September 18, 1989
Days to Decision 47 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 125d · This submission: 47d
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 227
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K894919.
MODEL DS-504 DYNASCOPE PATIENT MONITOR
K893405 · Fukuda Denshi USA, Inc. · Oct 1989
TYPE 9140 (SYSTEM ATHENA)
K894699 · S & W Medico Teknik · Oct 1989
TYPE PDU/CDU 9040 (SYSTEM ATHENA)
K894700 · S & W Medico Teknik · Oct 1989
HORIZON CENTRAL STATION
K892066 · Mennen Medical, Inc. · Jun 1989
HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S
K892006 · Healthdyne, Inc. · May 1989
TYPE 9210 ECG SYSTEM ATHENA
K884117 · S & W Medico Teknik · Apr 1989