Cleared Traditional

K850407 - NEONATAL MONITOR 309

K850407 is an FDA 510(k) clearance for NEONATAL MONITOR 309, manufactured by Rigel Medical Electronics, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K850407 · Rigel Medical Electronics, Inc. · Cardiovascular device
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Apr 1985
Decision
73d
Days
Class 2
Risk

K850407 is an FDA 510(k) clearance for the NEONATAL MONITOR 309. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Rigel Medical Electronics, Inc. (Mill Valley, US). The FDA issued a Cleared decision on April 18, 1985 after a review of 73 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 Rigel Medical Electronics, Inc. devices

FDA 510(k) Submission Details - K850407

510(k) Number K850407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1985
Decision Date April 18, 1985
Days to Decision 73 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 125d · This submission: 73d
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 K850407.
MODEL 78353B
K842817 · Hewlett-Packard Co. · Jun 1985
KONTRON SUPERMON 7210 PATIENT MONITOR
K844731 · Kontron Instruments, Inc. · May 1985
HORIZON 1000 CARDIAC MONITOR
K850880 · Mennen Medical, Inc. · Apr 1985
SIEMENS SIRECUST 404N NEONATAL MONITOR
K844187 · Siemens Medical Solutions USA, Inc. · Apr 1985
KONTRON MINIMON 7134 PATIENT MONITOR
K844215 · Kontron Instruments, Inc. · Apr 1985
KONTRON MINIMON 7132 PATIENT MONITOR
K844732 · Kontron Instruments, Inc. · Mar 1985