Cleared Traditional

K792077 - MODEL 1981 PRESSUROMETER DATA ANALYSIS

K792077 is an FDA 510(k) clearance for MODEL 1981 PRESSUROMETER DATA ANALYSIS, manufactured by Del Mar Avionics. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K792077

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.

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 K792077.
6-415 FILTER, ELEMENT, 170-C
K802925 · Lifecare Services, Inc. · Dec 1980
AMP PORTABLE PATIENT PRESSURE MONITOR
K802600 · American Medical Products, Inc. · Nov 1980
PRESSURE MONITOR, MODEL 1131B
K801110 · American Optical Corp. · May 1980
DINAMAP MODELS 1160 AND 1165
K782073 · Applied Medical Research · Feb 1979
MONITOR, PRESSURVEIL
K790135 · Concept, Inc. · Feb 1979
DINAMAP MODEL 846
K781053 · Applied Medical Research · Sep 1978