Cleared Abbreviated

K041778 - REIZEN TALKING BLOOD PRESSURE MONITOR

K041778 is an FDA 510(k) clearance for REIZEN TALKING BLOOD PRESSURE MONITOR, manufactured by Maxi-Aids, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Abbreviated 510(k) pathway after a 61-day FDA review.

K041778 · Maxi-Aids, Inc. · Cardiovascular device
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Aug 2004
Decision
61d
Days
Class 2
Risk

K041778 is an FDA 510(k) clearance for the REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Maxi-Aids, Inc. (Farmingdale, US). The FDA issued a Cleared decision on August 31, 2004 after a review of 61 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 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 Maxi-Aids, Inc. devices

FDA 510(k) Submission Details - K041778

510(k) Number K041778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2004
Decision Date August 31, 2004
Days to Decision 61 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 125d · This submission: 61d
Pathway characteristics
Standards-based clearance path.

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 555
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K041778.
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