The Devilbiss Co.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “The Devilbiss Co.” (first 1977, latest 1987), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 39 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 |
|---|---|---|---|
| CAW | Generator, Oxygen, Portable | 5 | 5 |
| CAF | Nebulizer (Direct Patient Interface) | 2 | 2 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 2 | 2 |
| BZC | Calculator, Pulmonary Function Data | 1 | 1 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent The Devilbiss Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K874041 | DEVILBISS MODEL 8500D | CAF | 1987-12-23 | 79 |
| K872094 | VACU-AIDE | JCX | 1987-10-15 | 136 |
| K872826 | ULTRA-NEB 99 ULTRASONIC NEBULIZER | CAF | 1987-09-04 | 50 |
| K872470 | DEVO/MC44 OXYGEN CONCENTRATOR | CAW | 1987-08-03 | 87 |
| K854520 | PULMO-AIDE MODEL 5610D | CCQ | 1985-12-09 | 27 |
| K852209 | DEVO/MC29 OXYGEN CONCENTRATOR MC29D | CAW | 1985-06-24 | 34 |
| K851695 | ULTRA-NEB 100 ULTRASONIC NEBULIZER | — | 1985-06-05 | 44 |
| K830174 | DE VO/44 OXYGEN CONCENTRATOR #444 | CAW | 1983-02-17 | 30 |
| K801526 | SURVEYOR I, RESPIRATORY COMPUTER SYSTEM | BZC | 1980-07-21 | 19 |
| K792385 | DEVO OXYGEN CONCENTRATOR, MODEL 955 | CAW | 1979-12-05 | 9 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named The Devilbiss Co..
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 The Devilbiss Co. (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.
- Devilbiss Health Care, Inc. (29 510(k)s)
- Devilbiss Healthcare, LLC (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under The Devilbiss Co.?
FDA lists 12 510(k) clearances under the applicant name “The Devilbiss Co.” (first 1977, latest 1987), across 6 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 The Devilbiss Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Devilbiss Co. is 39 days.
Which FDA product codes appear under The Devilbiss Co.?
The most frequent FDA product codes under this applicant name are CAW (Generator, Oxygen, Portable, 5); CAF (Nebulizer (Direct Patient Interface), 2); CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer), 2).
Next steps
- See all 12 The Devilbiss Co. clearances with predicates and recalls
- Run predicate analysis for product code CAW, The Devilbiss Co.'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.