Cleared Traditional

K792077 - MODEL 1981 PRESSUROMETER DATA ANALYSIS

K792077 is the FDA 510(k) clearance for MODEL 1981 PRESSUROMETER DATA ANALYSIS by Del Mar Avionics. It is a Class 2 Cardiovascular device (product code DSK) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K792077 · Del Mar Avionics · Cardiovascular device
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Dec 1979
Decision
50d
Days
Class 2
Risk

K792077 is an FDA 510(k) clearance for the MODEL 1981 PRESSUROMETER DATA ANALYSIS. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Del Mar Avionics (Walker, US). The FDA issued a Cleared decision on December 4, 1979 after a review of 50 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 Del Mar Avionics devices

Submission Details

510(k) Number K792077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1979
Decision Date December 04, 1979
Days to Decision 50 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
75d faster than avg
Panel avg: 125d · This submission: 50d
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 31
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K792077.
PATIENT MONITOR CM111, 112
K810178 · Honeywell, Inc. · Feb 1981
DUAL TRACE PATIENT MONITOR 116,118,120
K810179 · Honeywell, Inc. · Feb 1981
PRESSURE MONITOR, MODEL 1131B
K801110 · American Optical Corp. · May 1980
MONITOR, PRESSURVEIL
K790135 · Concept, Inc. · Feb 1979
MONITOR, CARDIAC, W/BLOOD PRESS.&TEMP
K772334 · Telectronics, Inc. · Feb 1978
CARDIAC OUTPUT MODULE-78231C
K772234 · Hewlett-Packard Co. · Jan 1978