Cleared Traditional

K844252 - MODEL 9300 TREND ANALYZING BIO-MONITOR SYS

K844252 is an FDA 510(k) clearance for MODEL 9300 TREND ANALYZING BIO-MONITOR SYS, manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K844252 · Medtronic Vascular · Cardiovascular device
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Jun 1985
Decision
236d
Days
Class 2
Risk

K844252 is an FDA 510(k) clearance for the MODEL 9300 TREND ANALYZING BIO-MONITOR SYS. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on June 26, 1985 after a review of 236 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Vascular devices

FDA 510(k) Submission Details - K844252

510(k) Number K844252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1984
Decision Date June 26, 1985
Days to Decision 236 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
111d slower than avg
Panel avg: 125d · This submission: 236d
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 852
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K844252.
OSCILLOMATE NEONATAL BLOOD PRESS. MONIT.-MODEL 901
K860196 · Cas Medical Systems, Inc. · May 1986
MPV-7201 NON-INVASIVE BLOOD PRESSURE MONITOR
K854370 · Nihon Kohden America, Inc. · Apr 1986
WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C
K852574 · Welch Allyn, Inc. · Mar 1986
ACCU-TRAC
K843055 · Olympic Medical Corp. · May 1985
BLOOD-PRESSURE ECG TRANSMITTER
K844310 · Instromedix, Inc. · Apr 1985
UNISONIC ELECTRONIC DIGITAL BP MONITOR EMB-4050
K850318 · Nihon Seimitsu Sokki Co., Ltd. · Apr 1985