Hoana Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Hoana Medical, Inc.” (first 2006, latest 2010), across 1 product code in 1 review panel. Median 510(k) review time under this name: 88 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 5 | 5 |
Review panels
- Cardiovascular (5)
Most recent Hoana Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K100745 | LIFEBED NETWORK PATIENT VIGILANCE SYSTEM | DRT | 2010-04-15 | 30 |
| K092037 | LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM | DRT | 2009-10-02 | 88 |
| K083534 | LIFEBED NETWORK PATIENT VIGILANCE SYSTEM | DRT | 2009-04-13 | 136 |
| K082366 | LIFEBED PATIENT VIGILANCE SYSTEM | DRT | 2008-09-26 | 39 |
| K052446 | LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM | DRT | 2006-02-02 | 148 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2007-11-07.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Hoana Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Hoana Medical, Inc.” (first 2006, latest 2010), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hoana Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hoana Medical, Inc. is 88 days.
Which FDA product codes appear under Hoana Medical, Inc.?
The most frequent FDA product codes under this applicant name are DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 5).
Next steps
- See all 5 Hoana Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRT, Hoana Medical, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.