Cleared Traditional

K780754 - NEONATAL MONITOR

K780754 is an FDA 510(k) clearance for NEONATAL MONITOR, manufactured by Applied Medical Research. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K780754 · Applied Medical Research · Cardiovascular device
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Jun 1978
Decision
36d
Days
Class 2
Risk

K780754 is an FDA 510(k) clearance for the NEONATAL MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Applied Medical Research (Mchenry, US). The FDA issued a Cleared decision on June 14, 1978 after a review of 36 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 Applied Medical Research devices

FDA 510(k) Submission Details - K780754

510(k) Number K780754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1978
Decision Date June 14, 1978
Days to Decision 36 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 125d · This submission: 36d
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 920
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K780754.
MODEL 1051, MONITOR
K790328 · Applied Medical Research · Mar 1979
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K781517 · Welch Allyn, Inc. · Jan 1979
PRESSURE INFUSION CUFF
K781556 · Abbott Laboratories · Oct 1978
TREND II ANEROID
K780598 · Abco Dealers, Inc. · Jun 1978
ACCES. ANALOG OUTPUT ADAPTOR MODEL 910
K780358 · Applied Medical Research · Apr 1978
ULTRASPHYG BLOOD PRESSURE OPTION
K780046 · Cavitron Corp. · Mar 1978