Cleared Traditional

K880066 - MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR

K880066 is an FDA 510(k) clearance for MODEL 303D AND 403D ADULT HEART RATE & ..., manufactured by Ivy Biomedical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K880066 · Ivy Biomedical Systems, Inc. · Cardiovascular device
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Mar 1988
Decision
71d
Days
Class 2
Risk

K880066 is an FDA 510(k) clearance for the MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Ivy Biomedical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on March 22, 1988 after a review of 71 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.

FDA 510(k) Submission Details - K880066

510(k) Number K880066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1988
Decision Date March 22, 1988
Days to Decision 71 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 125d · This submission: 71d
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 332
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K880066.
RIGEL MODEL MULTICARE 409
K875160 · Rigel Medical Electronics, Inc. · Jun 1988
MONITRON SYSTEM
K874148 · American Health Products, Inc. · Jun 1988
RM-301 PATIENT MONITOR
K880498 · Ppg Industries, Inc. · May 1988
MONITOR, ELECTROGRAPHIC
K874319 · Medac, Inc. · Mar 1988
CARE TELSTAT MODELS: MP 5010 AND MP 5020
K874844 · Care Systems, Inc. · Feb 1988
HEALTHDYNE APNEA/HEART MONITOR, MODEL 900
K874695 · Healthdyne, Inc. · Jan 1988
K880066 · MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR
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