Maersk Medical A/S: FDA clearances and approvals
Maersk Medical A/S has 9 FDA 510(k) clearances (first 1998, latest 2001), across 3 product codes in 3 review panels. Median 510(k) review time: 327 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | 5 | 5 |
| FPA | Set, Administration, Intravascular | 3 | 3 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 | 1 |
Review panels
Most recent Maersk Medical A/S 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011071 | PARADIGM QUICK-SET INFUSION SET | FPA | 2001-06-07 | 59 |
| K002138 | PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 | FPA | 2000-08-29 | 43 |
| K990115 | DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440 | DRX | 1999-12-06 | 327 |
| K990113 | DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560 | DRX | 1999-12-06 | 327 |
| K990112 | DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610 | DRX | 1999-12-06 | 327 |
| K990111 | DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570 | DRX | 1999-12-06 | 327 |
| K990110 | DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140 | DRX | 1999-12-06 | 327 |
| K991759 | MAERSK MEDICAL CONTOUR INFUSION SET | FPA | 1999-06-25 | 32 |
| K973364 | 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG | KNX | 1998-03-17 | 190 |
Recalls
openFDA lists no recalls under a recalling firm named Maersk Medical A/S.
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 Maersk Medical A/S have?
Maersk Medical A/S has 9 FDA 510(k) clearances (first 1998, latest 2001), across 3 product codes in 3 review panels.
How long does FDA take to clear Maersk Medical A/S's 510(k)s?
The median time from FDA receipt to decision across Maersk Medical A/S's cleared 510(k)s is 327 days.
What devices does Maersk Medical A/S make?
Its most frequent FDA product codes are DRX (Electrode, Electrocardiograph, 5); FPA (Set, Administration, Intravascular, 3); KNX (Collector, Urine, (And Accessories) For Indwelling Catheter, 1).
Has Maersk Medical A/S had device recalls?
openFDA lists no recalls under a recalling firm name matching Maersk Medical A/S. Related entities may recall under other names.
Next steps
- See all 9 Maersk Medical A/S clearances with predicates and recalls
- Run predicate analysis for product code DRX, Maersk Medical A/S'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.