Mallinckrodt Critical Care: FDA clearances and approvals
Mallinckrodt Critical Care has 92 FDA 510(k) clearances (first 1976, latest 1989), across 59 product codes in 10 review panels. Median 510(k) review time: 36 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | 10 | 10 |
| DQO | Catheter, Intravascular, Diagnostic | 9 | 9 |
| FLL | Continuous Measurement Thermometer | 7 | 7 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 4 | 4 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 2 | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 2 | 2 |
| CFR | Hexokinase, Glucose | 2 | 2 |
| GKL | Counter, Cell, Automated (Particle Counter) | 2 | 2 |
| IYT | System, Rebreathing, Radionuclide | 2 | 2 |
| JIX | Calibrator, Multi-Analyte Mixture | 2 | 2 |
Plus 49 more product codes.
Review panels
- Clinical Chemistry (37)
- Anesthesiology (16)
- Cardiovascular (15)
- General Hospital (10)
- Gastroenterology and Urology (5)
- Hematology (3)
- Immunology (2)
- Radiology (2)
- General and Plastic Surgery (1)
- Clinical Toxicology (1)
Most recent Mallinckrodt Critical Care 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880343 | BURNEY GALLBLADDER CATHETER KIT | FGE | 1989-05-01 | 461 |
| K874605 | HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR | KRI | 1988-02-02 | 85 |
| K874514 | HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE | FLL | 1988-01-29 | 88 |
| K874568 | HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR | FLL | 1988-01-06 | 62 |
| K874404 | HI-LO TEMP(R) SKIN TEMPERATURE SENSOR | FLL | 1987-11-06 | 9 |
| K873461 | LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) | BTR | 1987-11-06 | 70 |
| K873833 | THERMOCOUPLE ADAPTER | FLL | 1987-11-03 | 43 |
| K873004 | GUIDING CATHETER | DQO | 1987-09-15 | 42 |
| K871204 | CUFFED TRACHEAL TUBE (MULTIPLE) | BTR | 1987-04-21 | 27 |
| K862666 | UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) | BTR | 1986-08-01 | 18 |
82 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mallinckrodt Critical Care.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Mallinckrodt Critical Care's product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Mallinckrodt Critical Care have?
Mallinckrodt Critical Care has 92 FDA 510(k) clearances (first 1976, latest 1989), across 59 product codes in 10 review panels.
How long does FDA take to clear Mallinckrodt Critical Care's 510(k)s?
The median time from FDA receipt to decision across Mallinckrodt Critical Care's cleared 510(k)s is 36 days.
What devices does Mallinckrodt Critical Care make?
Its most frequent FDA product codes are BTR (Tube, Tracheal (W/Wo Connector), 10); DQO (Catheter, Intravascular, Diagnostic, 9); FLL (Continuous Measurement Thermometer, 7).
Has Mallinckrodt Critical Care had device recalls?
openFDA lists no recalls under a recalling firm name matching Mallinckrodt Critical Care. Related entities may recall under other names.
Next steps
- See all 92 Mallinckrodt Critical Care clearances with predicates and recalls
- Run predicate analysis for product code BTR, Mallinckrodt Critical Care'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.