Cleared Traditional

K893232 - MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM

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

K893232 · Camino Laboratories, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K893232

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
Combination Product No
PCCP Authorized No
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.

DSK Device Classification - Class 2, Special Controls

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 51
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K893232.
CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY
K912833 · Camino Laboratories, Inc. · Sep 1991
XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS.
K901514 · Ppg Industries, Inc. · Nov 1990
MEDILOG OPTIMA
K896535 · Oxford Medilog, Inc. · Jan 1990
TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA
K884118 · S & W Medico Teknik · Apr 1989
CARDIOCAP(TM) CMO-104 MONITOR
K882093 · Datex Division Instrumentarium Corp. · Jul 1988
TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/2420
K880079 · A&D Engineering, Inc. · Mar 1988