Cleared Traditional

K771449 - ARTEOIAL TONOMETER ML-105

K771449 is an FDA 510(k) clearance for ARTEOIAL TONOMETER ML-105, manufactured by Nicolet Biomedical Instruments. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K771449 · Nicolet Biomedical Instruments · Cardiovascular device
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Sep 1977
Decision
35d
Days
Class 2
Risk

K771449 is an FDA 510(k) clearance for the ARTEOIAL TONOMETER ML-105. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Nicolet Biomedical Instruments (Mchenry, US). The FDA issued a Cleared decision on September 6, 1977 after a review of 35 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 Nicolet Biomedical Instruments devices

FDA 510(k) Submission Details - K771449

510(k) Number K771449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1977
Decision Date September 06, 1977
Days to Decision 35 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
90d faster than avg
Panel avg: 125d · This submission: 35d
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 871
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K771449.
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K771897 · Applied Medical Research · Oct 1977
DINIMAP MODEL 827A
K771782 · Applied Medical Research · Oct 1977
PRESSUROMETER II
K771500 · Del Mar Avionics · Aug 1977
ELECTRONIC BLOOD PRESSURE UNIT
K761302 · Medline Industries, Inc. · Jan 1977