Cleared Traditional

K844252 - MODEL 9300 TREND ANALYZING BIO-MONITOR SYS

K844252 is the FDA 510(k) clearance for MODEL 9300 TREND ANALYZING BIO-MONITOR SYS by Medtronic Vascular. It is a Class 2 Cardiovascular device (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

Submission Details

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.

Device Classification

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 526
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K844252.
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ACCU-TRAC
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