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.

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 1225
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K844252.
COPAL UA-512 DIGITAL BLOOD PRESSURE MONITOR
K852564 · Takeda Medical, Inc. · Aug 1985
OMRON DIGITAL BP MONITOR HEM-400C
K851707 · Omron Tateisi Electronics Co. · Jul 1985
MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO
K851664 · Sharp Electronics Corp. · Jul 1985
SHARP DIGITAL BP MONITOR MB-371H
K850830 · Sharp Electronics Corp. · Jun 1985
NORELCO ELECTRONIC DIGITAL BLOOD PRESSURE METER
K852037 · Philips Park · Jun 1985
BP-800
K843010 · Pollenex Associated Mills, Inc. · May 1985
K844252 · MODEL 9300 TREND ANALYZING BIO-MONITOR SYS
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