Health Hero Network, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Health Hero Network, Inc.” (first 1999, latest 2008), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 28 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 4 | 4 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| DQA | Oximeter | 1 | 1 |
Review panels
- Cardiovascular (6)
- Anesthesiology (1)
- Clinical Chemistry (1)
Most recent Health Hero Network, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080091 | MODIFICATION TO:HEALTH BUDDY APPLIANCE | DRG | 2008-02-05 | 22 |
| K070543 | MODIFICATION TO HEALTH BUDDY APPLIANCE | DRG | 2007-03-28 | 30 |
| K063612 | MODIFICATION TO HEALTH BUDDY APPLIANCE | DRG | 2006-12-29 | 25 |
| K060843 | MODIFICATION TO HEALTH BUDDY APPLIANCE | DQA | 2006-04-20 | 23 |
| K050567 | HEALTH BUDDY APPLIANCE | DRG | 2005-04-05 | 32 |
| K042273 | MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY | DXN | 2004-08-31 | 8 |
| K040086 | HEALTH BUDDY WITH BUDDYLINK | DXN | 2004-03-10 | 54 |
| K993128 | HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER] | CGA | 1999-11-23 | 64 |
Recalls
openFDA lists no recalls under a recalling firm named Health Hero Network, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Health & Life Co., Ltd. (60 510(k)s)
- Health Products, Inc. (13 510(k)s)
- Health Line International Corporation (12 510(k)s)
- Health-Dent Intl., Inc. (8 510(k)s)
- Health Care Mfg., Inc. (7 510(k)s)
- Health Care Innovations, Inc. (5 510(k)s)
- Health Development Corp. (5 510(k)s)
- Health Images, Inc. (5 510(k)s)
- Health Beacons, Inc. (4 510(k)s)
- Health Improvement Assoc. (4 510(k)s)
- Health Scan, Inc. (4 510(k)s)
- Health Sense Intl., Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Health Hero Network, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Health Hero Network, Inc.” (first 1999, latest 2008), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Health Hero Network, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Health Hero Network, Inc. is 28 days.
Which FDA product codes appear under Health Hero Network, Inc.?
The most frequent FDA product codes under this applicant name are DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency, 4); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2); CGA (Glucose Oxidase, Glucose, 1).
Next steps
- See all 8 Health Hero Network, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRG, Health Hero Network, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.