Cleared Traditional

K040086 - HEALTH BUDDY WITH BUDDYLINK

K040086 is an FDA 510(k) clearance for HEALTH BUDDY WITH BUDDYLINK, manufactured by Health Hero Network, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K040086 · Health Hero Network, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
54d
Days
Class 2
Risk

K040086 is an FDA 510(k) clearance for the HEALTH BUDDY WITH BUDDYLINK. 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 March 10, 2004 after a review of 54 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Health Hero Network, Inc. devices

FDA 510(k) Submission Details - K040086

510(k) Number K040086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2004
Decision Date March 10, 2004
Days to Decision 54 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 125d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K040086.
AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XY
K033397 · Avita Corporation · Apr 2004
MODEL AVANT 2120 PULSE OXIMETER AND NIBP
K031487 · Nonin Medical, Inc. · Mar 2004
A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328
K040229 · A&D Engineering, Inc. · Mar 2004
DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-1862
K040309 · Nihon Seimitsu Sokki Co., Ltd. · Feb 2004
OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL
K032305 · Omron Healthcare, Inc. · Feb 2004
ZOLL M SERIES NIBP OPTION
K032363 · Zoll Medical Corp · Oct 2003