Mallinckrodt Inc., Liebel-Flarsheim Business: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Mallinckrodt Inc., Liebel-Flarsheim Business” (first 1997, latest 2009), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 148 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 |
|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | 7 | 7 |
| IZQ | Injector, Contrast Medium, Automatic | 1 | 1 |
Review panels
- General Hospital (8)
Most recent Mallinckrodt Inc., Liebel-Flarsheim Business 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082212 | SYRINGE WITH HANDI-FIL | DXT | 2009-01-22 | 169 |
| K073592 | OPTISTAR ELITE INJECTION SYSTEM | DXT | 2008-05-07 | 139 |
| K063503 | OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION | IZQ | 2007-04-27 | 158 |
| K042744 | OPTIV ANTAGE DH POWER INJECTION SYSTEM | DXT | 2004-11-30 | 57 |
| K031339 | OPTIBOLUS | DXT | 2003-07-11 | 74 |
| K022116 | ELPH INJECTION SYSTEM | DXT | 2002-07-26 | 25 |
| K984088 | OPTISTAR MR INJECTOR SYSTEM | DXT | 1999-12-06 | 385 |
| K963071 | ANGIOMAT ILLUMENA | DXT | 1997-09-23 | 412 |
Recalls
openFDA lists no recalls under a recalling firm named Mallinckrodt Inc., Liebel-Flarsheim Business.
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 Developpement France (7 510(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 Inc., Liebel-Flarsheim Business?
FDA lists 8 510(k) clearances under the applicant name “Mallinckrodt Inc., Liebel-Flarsheim Business” (first 1997, latest 2009), 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 Inc., Liebel-Flarsheim Business?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mallinckrodt Inc., Liebel-Flarsheim Business is 148 days.
Which FDA product codes appear under Mallinckrodt Inc., Liebel-Flarsheim Business?
The most frequent FDA product codes under this applicant name are DXT (Injector And Syringe, Angiographic, 7); IZQ (Injector, Contrast Medium, Automatic, 1).
Next steps
- See all 8 Mallinckrodt Inc., Liebel-Flarsheim Business clearances with predicates and recalls
- Run predicate analysis for product code DXT, Mallinckrodt Inc., Liebel-Flarsheim Business'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.