Cleared Traditional

K792075 - MODEL 1978 PRESSUROMETER III AMBULATORY

K792075 is an FDA 510(k) clearance for MODEL 1978 PRESSUROMETER III AMBULATORY, manufactured by Del Mar Avionics. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K792075 · Del Mar Avionics · Cardiovascular device
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Dec 1979
Decision
50d
Days
Class 2
Risk

K792075 is an FDA 510(k) clearance for the MODEL 1978 PRESSUROMETER III AMBULATORY. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Del Mar Avionics (Mchenry, 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 870.1130 - 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 - K792075

510(k) Number K792075 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.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 858
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K792075.
NON-INVASIVE, BLOOD PRESSURE MONITOR
K801657 · Biochem International, Inc. · Aug 1980
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K801187 · Conphar, Inc. · Jun 1980
DINAMAP RESEARCH MONITOR 1245
K800025 · Applied Medical Research · Feb 1980
DINAMAP MODEL 855
K791159 · Applied Medical Research · Jul 1979
HYPER CHEC, SPHYGMOMANOMETER ELECTRONIC
K791054 · C.R. Bard, Inc. · Jul 1979
QUICK-CHECK
K790277 · United States Surgical, A Division of Tyco Healthc · Mar 1979