Cleared Traditional

K780046 - ULTRASPHYG BLOOD PRESSURE OPTION

K780046 is an FDA 510(k) clearance for ULTRASPHYG BLOOD PRESSURE OPTION, manufactured by Cavitron Corp.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K780046 · Cavitron Corp. · Cardiovascular device
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Mar 1978
Decision
65d
Days
Class 2
Risk

K780046 is an FDA 510(k) clearance for the ULTRASPHYG BLOOD PRESSURE OPTION. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Cavitron Corp. (Mchenry, US). The FDA issued a Cleared decision on March 15, 1978 after a review of 65 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 Cavitron Corp. devices

FDA 510(k) Submission Details - K780046

510(k) Number K780046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1978
Decision Date March 15, 1978
Days to Decision 65 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
60d faster than avg
Panel avg: 125d · This submission: 65d
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 676
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K780046.
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K771394 · C.R. Bard, Inc. · Nov 1977
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K771931 · Applied Medical Research · Oct 1977