Cleared Traditional

K780046 - ULTRASPHYG BLOOD PRESSURE OPTION

K780046 is the FDA 510(k) clearance for ULTRASPHYG BLOOD PRESSURE OPTION by Cavitron Corp.. It is a Class 2 Cardiovascular device (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

Submission Details

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

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.

Device Classification

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 389

Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K780046.

AUTOMATIC BLOOD PRESSURE DEVICE

K781517 · Welch Allyn, Inc. · Jan 1979

PRESSURE INFUSION CUFF

K781556 · Abbott Laboratories · Oct 1978

TREND II ANEROID

K780598 · Abco Dealers, Inc. · Jun 1978

ELHCTRONIC SPHYGMOMANOMETER

K771393 · C.R. Bard, Inc. · Nov 1977

ELECTRONIC STETHESCOPE

K771394 · C.R. Bard, Inc. · Nov 1977

ELECTRONIC BLOOD PRESSURE UNIT

K761302 · Medline Industries, Inc. · Jan 1977

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K780046

Cavitron Corp.

Mchenry, IL · US

Regulatory profile

32 submissions 32 cleared

100% clearance rate · Active in Cardiovascular

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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