Devilbiss Health Care, Inc.: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Devilbiss Health Care, Inc.” (first 1989, latest 1997), across 12 product codes in 2 review panels. Median 510(k) review time under this name: 155 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 6 | 6 |
| BZD | Ventilator, Non-Continuous (Respirator) | 5 | 5 |
| CAW | Generator, Oxygen, Portable | 4 | 4 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 3 | 3 |
| BTI | Compressor, Air, Portable | 2 | 2 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 2 | 2 |
| NFB | Conserver, Oxygen | 2 | 2 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
| BYG | Mask, Oxygen | 1 | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 | 1 |
Plus 2 more product codes.
Review panels
- Anesthesiology (28)
- Ear, Nose and Throat (1)
Most recent Devilbiss Health Care, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K963349 | DEVILBISS 8650D | BTI | 1997-06-13 | 291 |
| K970289 | COMPRESSOR/NEBULIZER #3650 | CAF | 1997-04-15 | 81 |
| K961126 | PULSE DOSE SERIES | NFB | 1996-10-21 | 214 |
| K950849 | MODEL #7354 | BZD | 1996-02-08 | 349 |
| K952491 | MODEL 7355 | BZD | 1996-01-31 | 246 |
| K952249 | JET NEBULIZER | CAF | 1996-01-30 | 260 |
| K953815 | 5 LPM OXYGEN CONCENTRATOR | CAW | 1995-11-09 | 87 |
| K952037 | 3 LPM OXYGEN CONCENTRATOR | CAW | 1995-09-06 | 128 |
| K946095 | DEVILBISS MODEL 5500 | CAF | 1995-08-24 | 253 |
| K944611 | MODEL# 7500 SURVEYOR | MNR | 1995-04-21 | 214 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Devilbiss Health Care, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Devilbiss Health Care, Inc. (a text match, not an official crosswalk):
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.
- The Devilbiss Co. (12 510(k)s)
- Devilbiss Healthcare, LLC (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Devilbiss Health Care, Inc.?
FDA lists 29 510(k) clearances under the applicant name “Devilbiss Health Care, Inc.” (first 1989, latest 1997), across 12 product codes in 2 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 Devilbiss Health Care, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Devilbiss Health Care, Inc. is 155 days.
Which FDA product codes appear under Devilbiss Health Care, Inc.?
The most frequent FDA product codes under this applicant name are CAF (Nebulizer (Direct Patient Interface), 6); BZD (Ventilator, Non-Continuous (Respirator), 5); CAW (Generator, Oxygen, Portable, 4).
Next steps
- See all 29 Devilbiss Health Care, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Devilbiss Health Care, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.