Rossmax International , Ltd.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Rossmax International , Ltd.” (first 1998, latest 2006), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 74 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 14 | 14 |
| DPW | Flowmeter, Blood, Cardiovascular | 2 | 2 |
Review panels
- Cardiovascular (16)
Most recent Rossmax International , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K060342 | ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K | DXN | 2006-04-04 | 53 |
| K052727 | ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350 | DXN | 2005-12-16 | 78 |
| K021225 | ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I | DXN | 2002-05-22 | 34 |
| K013583 | ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS | DXN | 2002-01-17 | 79 |
| K013539 | ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS | DXN | 2002-01-17 | 85 |
| K011539 | ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS | DXN | 2001-07-20 | 63 |
| K011352 | ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS | DXN | 2001-07-20 | 78 |
| K011523 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138 | DXN | 2001-06-14 | 28 |
| K993460 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43 | DXN | 2000-01-11 | 90 |
| K993429 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z40 | DXN | 2000-01-07 | 87 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Rossmax International , Ltd..
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.
- Rossmax Internationl , Ltd. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Rossmax International , Ltd.?
FDA lists 16 510(k) clearances under the applicant name “Rossmax International , Ltd.” (first 1998, latest 2006), across 2 product codes 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 Rossmax International , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rossmax International , Ltd. is 74 days.
Which FDA product codes appear under Rossmax International , Ltd.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 14); DPW (Flowmeter, Blood, Cardiovascular, 2).
Next steps
- See all 16 Rossmax International , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Rossmax International , Ltd.'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.