Chad Therapeutics, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Chad Therapeutics, Inc.” (first 1983, latest 2008), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 70 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 |
|---|---|---|---|
| NFB | Conserver, Oxygen | 11 | 11 |
| BYX | Tubing, Pressure And Accessories | 2 | 2 |
| CAW | Generator, Oxygen, Portable | 2 | 2 |
| CAT | Cannula, Nasal, Oxygen | 1 | 1 |
| MNR | Ventilatory Effort Recorder | 1 | 1 |
Review panels
- Anesthesiology (17)
Most recent Chad Therapeutics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081176 | FLOCHANNEL | MNR | 2008-07-28 | 94 |
| K070740 | CHAD THERAPEUTICS BONSAI MODEL 800 | NFB | 2007-05-07 | 52 |
| K042142 | CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S | NFB | 2004-09-20 | 42 |
| K033364 | CHAD THERAPEUTICS SAGE | NFB | 2004-05-11 | 203 |
| K020475 | CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511 | NFB | 2002-07-05 | 143 |
| K013472 | TOTAL O2 | CAW | 2001-11-28 | 41 |
| K010389 | CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411 | NFB | 2001-03-23 | 42 |
| K003455 | MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401 | NFB | 2000-12-06 | 29 |
| K000890 | CHAD THERAPEUTICS OXYMATIC MODEL 401 | NFB | 2000-06-16 | 88 |
| K971889 | CHAD TOTAL O2 DELIVERY SYSTEM | CAW | 1997-11-17 | 180 |
7 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2005-03-25.
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.
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.
- Chad Labs Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Chad Therapeutics, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Chad Therapeutics, Inc.” (first 1983, latest 2008), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Chad Therapeutics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Chad Therapeutics, Inc. is 70 days.
Which FDA product codes appear under Chad Therapeutics, Inc.?
The most frequent FDA product codes under this applicant name are NFB (Conserver, Oxygen, 11); BYX (Tubing, Pressure And Accessories, 2); CAW (Generator, Oxygen, Portable, 2).
Next steps
- See all 17 Chad Therapeutics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NFB, Chad Therapeutics, 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.