Hommed, LLC: FDA clearances and approvals
Hommed, LLC has 8 FDA 510(k) clearances (first 2000, latest 2004), across 2 product codes in 2 review panels. Median 510(k) review time: 120 days.
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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 6 | 6 |
| DQA | Oximeter | 2 | 2 |
Review panels
- Cardiovascular (6)
- Anesthesiology (2)
Most recent Hommed, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040799 | HOMMED GENESIS PATIENT MONITOR SYSTEM WITH OPTIONS | DXN | 2004-08-18 | 142 |
| K040651 | HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEM | DXN | 2004-08-10 | 152 |
| K040032 | CENTRAL STATION, VERSION 3.3H | DXN | 2004-02-27 | 50 |
| K020184 | HOMMED CENTRAL STATION | DXN | 2002-04-22 | 94 |
| K014025 | HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER | DQA | 2002-04-09 | 124 |
| K003180 | HOMMED OBSERVER, MODEL I | DXN | 2001-06-28 | 260 |
| K004044 | HOMMED SENTRY III PATIENT MONITOR SYSTEM | DQA | 2001-03-02 | 63 |
| K993938 | THE HOMMED SENTRY, MODEL 1 SENTRY | DXN | 2000-03-15 | 117 |
Recalls
openFDA lists no recalls under a recalling firm named Hommed, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Hommed, LLC have?
Hommed, LLC has 8 FDA 510(k) clearances (first 2000, latest 2004), across 2 product codes in 2 review panels.
How long does FDA take to clear Hommed, LLC's 510(k)s?
The median time from FDA receipt to decision across Hommed, LLC's cleared 510(k)s is 120 days.
What devices does Hommed, LLC make?
Its most frequent FDA product codes are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 6); DQA (Oximeter, 2).
Has Hommed, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Hommed, LLC. Related entities may recall under other names.
Next steps
- See all 8 Hommed, LLC clearances with predicates and recalls
- Run predicate analysis for product code DXN, Hommed, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.