Cleared Traditional

K884645 - PATIENT MONITOR RIGEL MODEL MULTICARE 429

K884645 is an FDA 510(k) clearance for PATIENT MONITOR RIGEL MODEL MULTICARE 429, 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 87-day FDA review.

K884645 · Rigel Medical Electronics, Inc. · Cardiovascular device
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Feb 1989
Decision
87d
Days
Class 2
Risk

K884645 is an FDA 510(k) clearance for the PATIENT MONITOR RIGEL MODEL MULTICARE 429. 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 February 2, 1989 after a review of 87 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 - K884645

510(k) Number K884645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1988
Decision Date February 02, 1989
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
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 K884645.
TYPE 9210 ECG SYSTEM ATHENA
K884117 · S & W Medico Teknik · Apr 1989
MODEL 702 ECG/RESPIRATION/TEMPERATURE
K884455 · Ivy Biomedical Systems, Inc. · Mar 1989
PATIENT MONITOR MODEL 701
K884096 · Ivy Biomedical Systems, Inc. · Feb 1989
MINIMON 7134B PATIENT MONITOR
K883069 · Kontron Instruments, Inc. · Jan 1989
RM-301 PATIENT MONITOR
K880498 · Ppg Industries, Inc. · May 1988
MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR
K880066 · Ivy Biomedical Systems, Inc. · Mar 1988