Cleared Traditional

K875160 - RIGEL MODEL MULTICARE 409

K875160 is an FDA 510(k) clearance for RIGEL MODEL MULTICARE 409, 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 196-day FDA review.

K875160 · Rigel Medical Electronics, Inc. · Cardiovascular device
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Jun 1988
Decision
196d
Days
Class 2
Risk

K875160 is an FDA 510(k) clearance for the RIGEL MODEL MULTICARE 409. 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 June 28, 1988 after a review of 196 days - an extended review 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: 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 Rigel Medical Electronics, Inc. devices

FDA 510(k) Submission Details - K875160

510(k) Number K875160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1987
Decision Date June 28, 1988
Days to Decision 196 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 125d · This submission: 196d
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 K875160.
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
HEALTHDYNE APNEA/HEART MONITOR, MODEL 900
K874695 · Healthdyne, Inc. · Jan 1988