Mallinckrodt Group, Inc.: FDA clearances and approvals
Mallinckrodt Group, Inc. has 27 FDA 510(k) clearances (first 1976, latest 1995), across 15 product codes in 3 review panels. Median 510(k) review time: 97 days.
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 |
|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | 6 | 6 |
| KPX | Changer, Radiographic Film/Cassette | 4 | 4 |
| KPR | System, X-Ray, Stationary | 3 | 3 |
| IXR | Table, Radiographic, Tilting | 2 | 2 |
| KQS | Table, Cystometric, Non-Electric And Accessories | 2 | 2 |
| FMW | Cover, Mattress (Medical Purposes) | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| FYA | Gown, Surgical | 1 | 1 |
| IXA | Cassette, Radiographic Film | 1 | 1 |
| IZP | Programmer, Changer, Film/Cassette, Radiographic | 1 | 1 |
Plus 5 more product codes.
Review panels
- Radiology (14)
- General Hospital (10)
- Gastroenterology and Urology (3)
Most recent Mallinckrodt Group, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945053 | LF CT HIG PRESSURE CATHETERS | FOZ | 1995-05-19 | 217 |
| K945140 | URO-FLO | LJH | 1995-03-08 | 139 |
| K943581 | HYDRADJUST IV UROLOGICAL TABLE | IXR | 1995-01-04 | 166 |
| K943122 | SURGICAL DRAPES | KKX | 1994-09-07 | 70 |
| K934664 | HYDRAGOWN | FYA | 1994-05-24 | 238 |
| K920742 | HYDRAJUST IV UROLOGICAL TABLE | IXR | 1992-04-27 | 68 |
| K912944 | CT 8000 DIGITAL INJECTION SYSTEM | DXT | 1992-02-04 | 214 |
| K913264 | HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE | LLZ | 1991-11-01 | 101 |
| K905789 | FRANKLIN 9000 WALL STAND | KPX | 1991-05-20 | 144 |
| K904147 | HUGH YOUNG II UROLOGICAL X-RAY SYSTEM | KPR | 1990-12-13 | 97 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mallinckrodt Group, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances does Mallinckrodt Group, Inc. have?
Mallinckrodt Group, Inc. has 27 FDA 510(k) clearances (first 1976, latest 1995), across 15 product codes in 3 review panels.
How long does FDA take to clear Mallinckrodt Group, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Mallinckrodt Group, Inc.'s cleared 510(k)s is 97 days.
What devices does Mallinckrodt Group, Inc. make?
Its most frequent FDA product codes are DXT (Injector And Syringe, Angiographic, 6); KPX (Changer, Radiographic Film/Cassette, 4); KPR (System, X-Ray, Stationary, 3).
Has Mallinckrodt Group, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Mallinckrodt Group, Inc. Related entities may recall under other names.
Next steps
- See all 27 Mallinckrodt Group, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXT, Mallinckrodt Group, Inc.'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.