Mallinckrodt Medical: FDA clearances and approvals
Mallinckrodt Medical has 43 FDA 510(k) clearances (first 1990, latest 2008), across 18 product codes in 5 review panels. Median 510(k) review time: 85 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 |
|---|---|---|---|
| JOH | Tube Tracheostomy And Tube Cuff | 7 | 7 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 5 | 5 |
| CAH | Filter, Bacterial, Breathing-Circuit | 5 | 5 |
| DQY | Catheter, Percutaneous | 5 | 5 |
| BTR | Tube, Tracheal (W/Wo Connector) | 4 | 4 |
| DQO | Catheter, Intravascular, Diagnostic | 3 | 3 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 2 | 2 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 | 2 |
| BSJ | Mask, Gas, Anesthetic | 1 | 1 |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
Plus 8 more product codes.
Review panels
- Anesthesiology (22)
- Cardiovascular (12)
- General Hospital (6)
- Gastroenterology and Urology (2)
- Radiology (1)
Most recent Mallinckrodt Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082520 | SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES | BTR | 2008-10-02 | 30 |
| K051416 | SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA | JOH | 2005-06-16 | 15 |
| K972258 | HI-CARE CLOSED SUCTION SYSTEM | BSY | 1997-12-29 | 195 |
| K971267 | SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF | JOH | 1997-09-25 | 174 |
| K963732 | PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA | JOH | 1997-06-26 | 282 |
| K955721 | CUFFED OROPHARYNGEAL AIRWAY (COPA) | CAE | 1997-03-28 | 466 |
| K965132 | HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES | BTR | 1997-03-20 | 87 |
| K962045 | ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT | CAH | 1996-11-26 | 182 |
| K962173 | SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES | JOH | 1996-10-04 | 121 |
| K955680 | SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED | JOH | 1996-03-13 | 90 |
33 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mallinckrodt Medical.
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 Medical have?
Mallinckrodt Medical has 43 FDA 510(k) clearances (first 1990, latest 2008), across 18 product codes in 5 review panels.
How long does FDA take to clear Mallinckrodt Medical's 510(k)s?
The median time from FDA receipt to decision across Mallinckrodt Medical's cleared 510(k)s is 85 days.
What devices does Mallinckrodt Medical make?
Its most frequent FDA product codes are JOH (Tube Tracheostomy And Tube Cuff, 7); BYD (Condenser, Heat And Moisture (Artificial Nose), 5); CAH (Filter, Bacterial, Breathing-Circuit, 5).
Has Mallinckrodt Medical had device recalls?
openFDA lists no recalls under a recalling firm name matching Mallinckrodt Medical. Related entities may recall under other names.
Next steps
- See all 43 Mallinckrodt Medical clearances with predicates and recalls
- Run predicate analysis for product code JOH, Mallinckrodt Medical'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.