Cleared Special

K042273 - MODIFICATION TO HEALTH BUDDY WITH DEVIC...

K042273 is an FDA 510(k) clearance for MODIFICATION TO HEALTH BUDDY WITH DEVIC..., manufactured by Health Hero Network, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Special 510(k) pathway after a 8-day FDA review.

K042273 · Health Hero Network, Inc. · Cardiovascular device
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Aug 2004
Decision
8d
Days
Class 2
Risk

K042273 is an FDA 510(k) clearance for the MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Health Hero Network, Inc. (Mountain View, US). The FDA issued a Cleared decision on August 31, 2004 after a review of 8 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Health Hero Network, Inc. devices

FDA 510(k) Submission Details - K042273

510(k) Number K042273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2004
Decision Date August 31, 2004
Days to Decision 8 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 125d · This submission: 8d
Pathway characteristics
Modification to existing cleared device.

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 623
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