Cleared Abbreviated

K033216 - BZ-576 NON-INVASIVE AUTOMATIC BLOOD PRESSURE MONITOR

K033216 is an FDA 510(k) clearance for BZ-576 NON-INVASIVE AUTOMATIC BLOOD PRE..., manufactured by The Buzz Group, LLC. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Abbreviated 510(k) pathway after a 214-day FDA review.

K033216 · The Buzz Group, LLC · Cardiovascular device
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May 2004
Decision
214d
Days
Class 2
Risk

K033216 is an FDA 510(k) clearance for the BZ-576 NON-INVASIVE AUTOMATIC BLOOD PRESSURE MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by The Buzz Group, LLC (Deer Field, US). The FDA issued a Cleared decision on May 4, 2004 after a review of 214 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 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 The Buzz Group, LLC devices

FDA 510(k) Submission Details - K033216

510(k) Number K033216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2003
Decision Date May 04, 2004
Days to Decision 214 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
89d slower than avg
Panel avg: 125d · This submission: 214d
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 905
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