Cleared Traditional

OLLI 565 (K820540) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K820540 · Kone Instruments, Inc. · Cardiovascular device
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Apr 1982
Decision
30d
Days
Class 2
Risk

K820540 is an FDA 510(k) clearance for the OLLI 565. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Kone Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 1, 1982 after a review of 30 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 Kone Instruments, Inc. devices

Submission Details

510(k) Number K820540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1982
Decision Date April 01, 1982
Days to Decision 30 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 54
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K820540.
SIGNAL DISTRIBUTION NETWORK #78581A
K822695 · Hewlett-Packard Co. · Oct 1982
MODELS 78504A & 78508A PATIENT MON. SYS
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CARDIAC MONITOR - RATE ALARM
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NIHON KOHDEN HEART MONITORS OMP 7101-02
K813444 · Nihon Kohden America, Inc. · Dec 1981
RESIDENT BEDSIDE MONITOR
K811216 · Abbott Laboratories · Jul 1981
PDS COMPUTER UNIT/VIDEO TERMINAL
K801761 · General Electric Co. · Aug 1980