Douglas Medical Products Corp.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Douglas Medical Products Corp.” (first 1992, latest 2017), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 176 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 | 1 | 277 |
| 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, 510(k)s cleared under the name Douglas Medical Products Corp. took a median 277 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 173 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 11 | 11 |
| HRX | Arthroscope | 2 | 2 |
| KPE | Container, I.V. | 2 | 2 |
| BRZ | Set, Blood Transfusion | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| FPB | Filter, Infusion Line | 1 | 1 |
| FPK | Tubing, Fluid Delivery | 1 | 1 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 1 | 1 |
Review panels
- General Hospital (18)
- Orthopedic (2)
Most recent Douglas Medical Products Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162951 | TUBETECH IV Administration Set | FPA | 2017-07-28 | 277 |
| K961155 | SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908 | LJS | 1996-06-18 | 88 |
| K954428 | SOLOPICC 24 (60CM) 20GA CATHETER | FOZ | 1996-03-28 | 188 |
| K941628 | 40 MICRON BLOOD TRANSFUSION FILTER | FPB | 1995-02-16 | 318 |
| K942101 | 4-LEAD IRRIGATION SET | HRX | 1994-09-30 | 151 |
| K941453 | CHECK VALVE SOLUTION SET | FPA | 1994-08-16 | 144 |
| K930854 | SOLUTION SET WITH .2 MICRON FILTER | FPA | 1994-01-14 | 330 |
| K932637 | SUBCUTANEOUS INFUSION SET | FPA | 1994-01-07 | 219 |
| K931659 | 3 LEAD CONNECTOR | FPA | 1994-01-07 | 277 |
| K931658 | IN-LINE BURETTE SET | FPA | 1993-12-21 | 260 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Douglas Medical Products Corp..
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.
- Douglas James Donaldson Compliance Services (5 510(k)s)
- Douglas Scientific Products (2 510(k)s)
- Douglas Bueschel (1 510(k)s)
- Douglas C. Mckee & Co. (1 510(k)s)
- Douglas C. Yoon, Dds (1 510(k)s)
- Douglas Manufacturer Co. (1 510(k)s)
- Douglas Products (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Douglas Medical Products Corp.?
FDA lists 20 510(k) clearances under the applicant name “Douglas Medical Products Corp.” (first 1992, latest 2017), across 8 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 Douglas Medical Products Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Douglas Medical Products Corp. is 176 days.
Which FDA product codes appear under Douglas Medical Products Corp.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 11); HRX (Arthroscope, 2); KPE (Container, I.V., 2).
Next steps
- See all 20 Douglas Medical Products Corp. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Douglas Medical Products Corp.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.