Breathe Technologies, Inc.: FDA clearances and approvals
Breathe Technologies, Inc. has 8 FDA 510(k) clearances (first 2009, latest 2017), across 3 product codes in 1 review panel. Median 510(k) review time: 174 days. It is the industry lead sponsor of 4 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 130 |
| 2014 | 1 | 280 |
| 2015 | 1 | 330 |
| 2016 | 0 | — |
| 2017 | 1 | 219 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Breathe Technologies, Inc.'s cleared 510(k)s took a median 219 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 233 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ONZ | Mechanical Ventilator | 5 | 5 |
| CBK | Ventilator, Continuous, Facility Use | 2 | 2 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 | 1 |
Review panels
- Anesthesiology (8)
Most recent Breathe Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170037 | Breathe Technologies Life2000 Ventilation System | CBK | 2017-08-11 | 219 |
| K141943 | BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM | CBK | 2015-06-12 | 330 |
| K131562 | BREATHE NIOV VENTILATION SYSTEM | ONZ | 2014-03-06 | 280 |
| K130037 | BREATHE CPAP SYSTEM | BZD | 2013-05-17 | 130 |
| K103345 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) | ONZ | 2011-02-11 | 88 |
| K102525 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) | ONZ | 2010-12-02 | 91 |
| K100528 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S | ONZ | 2010-04-23 | 58 |
| K082982 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES | ONZ | 2009-07-20 | 287 |
Recalls
openFDA lists no recalls under a recalling firm named Breathe Technologies, Inc..
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.
Device clinical trials
Breathe Technologies, Inc. is the industry lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01596023: Evaluation of Breathe NIOV System on Work of Breathing in Chronic Obstructive Lung Disease Patients (Completed, started 2012-05)
- NCT01355978: Non-invasive Ventilation System in Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) (Completed, started 2011-08)
- NCT01372462: Effects of the Breathe Technologies Ventilation System in Subjects With Chronic Obstructive Pulmonary Disease (Completed, started 2011-07)
- NCT01347931: In-home Evaluation of a Noninvasive Open Ventilation System in Patients With Severe Respiratory Insufficiency (Completed, started 2011-05)
Frequently asked questions
How many FDA 510(k) clearances does Breathe Technologies, Inc. have?
Breathe Technologies, Inc. has 8 FDA 510(k) clearances (first 2009, latest 2017), across 3 product codes in 1 review panel.
How long does FDA take to clear Breathe Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Breathe Technologies, Inc.'s cleared 510(k)s is 174 days.
What devices does Breathe Technologies, Inc. make?
Its most frequent FDA product codes are ONZ (Mechanical Ventilator, 5); CBK (Ventilator, Continuous, Facility Use, 2); BZD (Ventilator, Non-Continuous (Respirator), 1).
Has Breathe Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Breathe Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 8 Breathe Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ONZ, Breathe Technologies, Inc.'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.