Cleared Traditional

K790135 - MONITOR

K790135 is an FDA 510(k) clearance for MONITOR, manufactured by Concept, Inc.. The device is a Class 2 Cardiovascular device with product code DSK cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K790135 · Concept, Inc. · Cardiovascular device
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Feb 1979
Decision
22d
Days
Class 2
Risk

K790135 is an FDA 510(k) clearance for the MONITOR, PRESSURVEIL. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Concept, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1979 after a review of 22 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 Concept, Inc. devices

FDA 510(k) Submission Details - K790135

510(k) Number K790135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1979
Decision Date February 13, 1979
Days to Decision 22 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
103d faster than avg
Panel avg: 125d · This submission: 22d
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 34
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K790135.
AMP PORTABLE PATIENT PRESSURE MONITOR
K802600 · American Medical Products, Inc. · Nov 1980
PRESSURE MONITOR, MODEL 1131B
K801110 · American Optical Corp. · May 1980
MODEL 1981 PRESSUROMETER DATA ANALYSIS
K792077 · Del Mar Avionics · Dec 1979
GOULD-STATHAM SP1405 PRESSURE MONITOR
K780798 · Gould, Inc. · Jun 1978
MONITOR, CARDIAC, W/BLOOD PRESS.&TEMP
K772334 · Telectronics, Inc. · Feb 1978
CARDIAC OUTPUT MODULE-78231C
K772234 · Hewlett-Packard Co. · Jan 1978