Cleared Traditional

K893232 - MODEL V420 DIRECT PRESSURE MONITOR & 42...

K893232 is the FDA 510(k) clearance for MODEL V420 DIRECT PRESSURE MONITOR & 42... by Camino Laboratories, Inc.. It is a Class 2 Cardiovascular device (product code DSK) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K893232 · Camino Laboratories, Inc. · Cardiovascular device
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Jul 1989
Decision
77d
Days
Class 2
Risk

K893232 is an FDA 510(k) clearance for the MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Camino Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on July 14, 1989 after a review of 77 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 Camino Laboratories, Inc. devices

Submission Details

510(k) Number K893232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1989
Decision Date July 14, 1989
Days to Decision 77 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
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 32
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K893232.
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MEDILOG OPTIMA
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K884118 · S & W Medico Teknik · Apr 1989
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K882093 · Datex Division Instrumentarium Corp. · Jul 1988
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K880079 · A&D Engineering, Inc. · Mar 1988