Cleared Traditional

PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403 (K862647) - FDA 510(k) Clearance

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

K862647 · Ivy Biomedical Systems, Inc. · Cardiovascular device
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Aug 1986
Decision
38d
Days
Class 2
Risk

K862647 is an FDA 510(k) clearance for the PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Ivy Biomedical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on August 18, 1986 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1110 - 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 Ivy Biomedical Systems, Inc. devices

Submission Details

510(k) Number K862647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1986
Decision Date August 18, 1986
Days to Decision 38 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 125d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSK Computer, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1110
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 - DSK Computer, Blood-pressure

All 76
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K862647.
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MODEL 78553A PRESSURE PLUG-IN MODULE
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K772234 · Hewlett-Packard Co. · Jan 1978
CARDIAC OUTPUT COMPUTER MODEL 701
K771977 · Instrumentation Laboratory CO · Jan 1978