Devilbiss Healthcare, LLC: FDA clearances and approvals
Devilbiss Healthcare, LLC has 7 FDA 510(k) clearances (first 2011, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time: 132 days. Since 2017 its median was 203 days, against 220 days for all cleared 510(k)s in the same product codes. openFDA lists 6 product recalls by a recalling firm named Devilbiss Healthcare, LLC. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 119 |
| 2015 | 1 | 268 |
| 2016 | 1 | 115 |
| 2017 | 0 | — |
| 2018 | 1 | 203 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 267 |
| 2026 | 1 | 132 |
Review time against the same product codes
Since 2017, Devilbiss Healthcare, LLC's cleared 510(k)s took a median 203 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 220 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 4 | 4 |
| CAW | Generator, Oxygen, Portable | 3 | 3 |
Review panels
- Anesthesiology (7)
Most recent Devilbiss Healthcare, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555) | CAW | 2026-03-26 | 132 |
| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) | CAW | 2025-12-09 | 267 |
| K172648 | Drive DeVilbiss iGo 2 Portable Oxygen Concentrator | CAW | 2018-03-23 | 203 |
| K152810 | DeVilbiss DV6WM Wireless Modem | BZD | 2016-01-21 | 115 |
| K143677 | DeVilbiss Intellipap2/DeVilbiss BLUE | BZD | 2015-09-18 | 268 |
| K140880 | DEVILBISS SMARTLINK II SYSTEM | BZD | 2014-08-04 | 119 |
| K112220 | DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL | BZD | 2011-11-22 | 112 |
Recalls
6 product recalls in 6 recall events; 3 initiated in the last five years. Most recent: 2023-03-09.
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
Devilbiss Healthcare, LLC is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01797705: Revised Algorithm for Next Generation DeVilbiss Healthcare AutoAdjust Continuous Positive Airway Pressure (CPAP) (Completed, started 2013-01)
- NCT01203956: DeVilbiss AutoAdjust With SmartFlex Comparative Study (Completed, started 2010-09)
Frequently asked questions
How many FDA 510(k) clearances does Devilbiss Healthcare, LLC have?
Devilbiss Healthcare, LLC has 7 FDA 510(k) clearances (first 2011, latest 2026), across 2 product codes in 1 review panel.
How long does FDA take to clear Devilbiss Healthcare, LLC's 510(k)s?
The median time from FDA receipt to decision across Devilbiss Healthcare, LLC's cleared 510(k)s is 132 days. Since 2017: 203 days, versus 220 days for all cleared 510(k)s in the same product codes.
What devices does Devilbiss Healthcare, LLC make?
Its most frequent FDA product codes are BZD (Ventilator, Non-Continuous (Respirator), 4); CAW (Generator, Oxygen, Portable, 3).
Has Devilbiss Healthcare, LLC had device recalls?
openFDA lists 6 product recalls in 6 recall events by a recalling firm whose name matches Devilbiss Healthcare, LLC; the most recent began 2023-03-09. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 Devilbiss Healthcare, LLC clearances with predicates and recalls
- Run predicate analysis for product code BZD, Devilbiss Healthcare, 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.