Ventus Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Ventus Medical, Inc.” (first 2008, latest 2012), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 100 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 | 99 |
| 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 |
|---|---|---|---|
| OHP | Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea | 3 | 3 |
| LWF | Dilator, Nasal | 1 | 1 |
| MNR | Ventilatory Effort Recorder | 1 | 1 |
Review panels
- Dental (3)
- Anesthesiology (1)
- Ear, Nose and Throat (1)
Most recent Ventus Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120665 | INVENT SNORING DEVICE | LWF | 2012-06-12 | 99 |
| K102404 | PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50) | OHP | 2010-12-02 | 100 |
| K090398 | PROVENT PROFESSIONAL SLEEP APNEA THERAPY | OHP | 2009-04-03 | 45 |
| K080983 | PROVENT NASAL CANNULA | MNR | 2008-08-07 | 122 |
| K071560 | PROVENT NASAL DILATOR, MODEL BR2 | OHP | 2008-02-08 | 246 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2012-02-03.
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.
Device clinical trials
An industry sponsor named Ventus Medical, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00849043: Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-hypopnea (Completed, started 2009-02)
- NCT00772044: Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea (Completed, started 2008-11)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ventus Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Ventus Medical, Inc.” (first 2008, latest 2012), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ventus Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ventus Medical, Inc. is 100 days.
Which FDA product codes appear under Ventus Medical, Inc.?
The most frequent FDA product codes under this applicant name are OHP (Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea, 3); LWF (Dilator, Nasal, 1); MNR (Ventilatory Effort Recorder, 1).
Next steps
- See all 5 Ventus Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OHP, Ventus 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.