Cleared Traditional

K912833 - CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY

K912833 is an FDA 510(k) clearance for CAMINO MODEL M420: MONIT INTER W/MEAN P..., 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 89-day FDA review.

K912833 · Camino Laboratories, Inc. · Cardiovascular device
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Sep 1991
Decision
89d
Days
Class 2
Risk

K912833 is an FDA 510(k) clearance for the CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY. 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 September 23, 1991 after a review of 89 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 - K912833

510(k) Number K912833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1991
Decision Date September 23, 1991
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 125d · This submission: 89d
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 K912833.
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