Cleared Abbreviated

K010751 - BPFONE

K010751 is the FDA 510(k) clearance for BPFONE by Medical Monitors Pty Limited. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K010751 · Medical Monitors Pty Limited · Cardiovascular device
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Jun 2001
Decision
90d
Days
Class 2
Risk

K010751 is an FDA 510(k) clearance for the BPFONE, MODEL UA 767IT. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Medical Monitors Pty Limited (Randwick Nsw, AU). The FDA issued a Cleared decision on June 11, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Medical Monitors Pty Limited devices

Submission Details

510(k) Number K010751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2001
Decision Date June 11, 2001
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

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 520
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