eVent Medical, Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “eVent Medical, Ltd.” (first 2002, latest 2013), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 231 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 | 1 | 364 |
| 2013 | 1 | 277 |
| 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 6 | 6 |
| BTI | Compressor, Air, Portable | 1 | 1 |
Review panels
- Anesthesiology (7)
Most recent eVent Medical, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130178 | INSPIRATION VENTILATOR SYSTEM 5I/7I | CBK | 2013-10-29 | 277 |
| K113743 | EVOLUTION 3E VENTILATOR | CBK | 2012-12-18 | 364 |
| K072590 | INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM | CBK | 2008-01-04 | 112 |
| K051550 | INSPIRATION VENTILATOR SYSTEM | CBK | 2005-07-12 | 29 |
| K040220 | MEDICAL AIR COMPRESSOR | BTI | 2004-06-09 | 128 |
| K030341 | MODIFICATION TO INSPIRATION VENTILATOR SYSTEM | CBK | 2004-01-16 | 347 |
| K021112 | INSPIRATION VENTILATOR SYSTEM | CBK | 2002-11-22 | 231 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2015-10-13.
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 eVent Medical, Ltd.?
FDA lists 7 510(k) clearances under the applicant name “eVent Medical, Ltd.” (first 2002, latest 2013), 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 eVent Medical, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name eVent Medical, Ltd. is 231 days.
Which FDA product codes appear under eVent Medical, Ltd.?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 6); BTI (Compressor, Air, Portable, 1).
Next steps
- See all 7 eVent Medical, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code CBK, eVent Medical, 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.