Mallinckrodt Developpement France: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Mallinckrodt Developpement France” (first 2000, latest 2008), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 87 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 |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 6 | 6 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
Review panels
- Anesthesiology (7)
Most recent Mallinckrodt Developpement France 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082237 | PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST | BZD | 2008-10-09 | 63 |
| K080439 | SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE | BZD | 2008-05-16 | 87 |
| K071575 | SANDMAN INTRO | BZD | 2007-09-10 | 94 |
| K063501 | KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US | BZD | 2007-04-06 | 137 |
| K042184 | GOODKNIGHT H20, MODEL M-114600-00 | BTT | 2005-01-10 | 151 |
| K041819 | GOODKNIGHT 425, MODELM-114500-00 | BZD | 2004-07-22 | 16 |
| K001845 | MALLINCKRODT, GOODKNIGHT 418S | BZD | 2000-07-05 | 16 |
Recalls
openFDA lists no recalls under a recalling firm named Mallinckrodt Developpement France.
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.
- Mallinckrodt Critical Care (92 510(k)s)
- Mallinckrodt Medical (43 510(k)s)
- Mallinckrodt Group, Inc. (27 510(k)s)
- Mallinckrodt Inc., Liebel-Flarsheim Business (8 510(k)s)
- Mallinckrodt Manufacturing, LLC (4 510(k)s)
- Mallinckrodt Medical Tpi, Inc. (4 510(k)s)
- Mallinckrodt Anesthesia Products (3 510(k)s)
- Mallinckrodt, Inc. (2 510(k)s)
- Mallinckrodt Dar S.R.L. (2 510(k)s)
- Mallinckrodt Sensor Systems, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mallinckrodt Developpement France?
FDA lists 7 510(k) clearances under the applicant name “Mallinckrodt Developpement France” (first 2000, latest 2008), across 2 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 Mallinckrodt Developpement France?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mallinckrodt Developpement France is 87 days.
Which FDA product codes appear under Mallinckrodt Developpement France?
The most frequent FDA product codes under this applicant name are BZD (Ventilator, Non-Continuous (Respirator), 6); BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 1).
Next steps
- See all 7 Mallinckrodt Developpement France clearances with predicates and recalls
- Run predicate analysis for product code BZD, Mallinckrodt Developpement France'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.