Cleared Traditional

K782000 - MONITOR, NON-INVASIVE BLOOD PRESSURE

K782000 is an FDA 510(k) clearance for MONITOR, manufactured by Automated Screening Devices. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K782000 · Automated Screening Devices · Cardiovascular device
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Dec 1978
Decision
13d
Days
Class 2
Risk

K782000 is an FDA 510(k) clearance for the MONITOR, NON-INVASIVE BLOOD PRESSURE. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Automated Screening Devices (Mchenry, US). The FDA issued a Cleared decision on December 5, 1978 after a review of 13 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 Automated Screening Devices devices

FDA 510(k) Submission Details - K782000

510(k) Number K782000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1978
Decision Date December 05, 1978
Days to Decision 13 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 125d · This submission: 13d
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 928
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K782000.
QUICK-CHECK
K790277 · United States Surgical, A Division of Tyco Healthc · Mar 1979
MODEL 1051, MONITOR
K790328 · Applied Medical Research · Mar 1979
AUTOMATIC BLOOD PRESSURE DEVICE
K781517 · Welch Allyn, Inc. · Jan 1979
PRESSURE INFUSION CUFF
K781556 · Abbott Laboratories · Oct 1978
NEONATAL MONITOR
K780754 · Applied Medical Research · Jun 1978
TREND II ANEROID
K780598 · Abco Dealers, Inc. · Jun 1978