Honeywell Hommed, LLC: FDA clearances and approvals
Honeywell Hommed, LLC has 8 FDA 510(k) clearances (first 2006, latest 2016), across 2 product codes in 1 review panel. Median 510(k) review time: 84 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 116 |
| 2013 | 0 | — |
| 2014 | 1 | 146 |
| 2015 | 0 | — |
| 2016 | 1 | 158 |
| 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 | 6 | 6 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
Review panels
- Cardiovascular (8)
Most recent Honeywell Hommed, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153719 | LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream | DRG | 2016-06-03 | 158 |
| K141792 | GENESIS TOUCH SYSTEM | DRG | 2014-11-25 | 146 |
| K112858 | GENESIS TOUCH SYSTEM | DRG | 2012-01-24 | 116 |
| K101242 | GENESIS DM MODEL: 6053000A1 | DRG | 2010-06-11 | 39 |
| K072272 | HONEYWELL HOMMED CENTRAL STATION 4.0 | DXN | 2007-09-07 | 23 |
| K061088 | SENTRY OTC MONITOR | DRG | 2006-06-09 | 52 |
| K061087 | GENESIS OTC MONITOR | DRG | 2006-06-09 | 52 |
| K053453 | HOMMED CENTRAL STATION, VERSION 3.5 | DXN | 2006-05-05 | 144 |
Recalls
openFDA lists no recalls under a recalling firm named Honeywell 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 Honeywell Hommed, LLC have?
Honeywell Hommed, LLC has 8 FDA 510(k) clearances (first 2006, latest 2016), across 2 product codes in 1 review panel.
How long does FDA take to clear Honeywell Hommed, LLC's 510(k)s?
The median time from FDA receipt to decision across Honeywell Hommed, LLC's cleared 510(k)s is 84 days.
What devices does Honeywell Hommed, LLC make?
Its most frequent FDA product codes are DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency, 6); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2).
Has Honeywell Hommed, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Honeywell Hommed, LLC. Related entities may recall under other names.
Next steps
- See all 8 Honeywell Hommed, LLC clearances with predicates and recalls
- Run predicate analysis for product code DRG, Honeywell 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.