Maquet Cardiopulmonary, AG: FDA filings under this applicant name
FDA lists 44 510(k) clearances under the applicant name “Maquet Cardiopulmonary, AG” (first 2005, latest 2015), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 138 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Getinge, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 7 | 66 |
| 2014 | 3 | 180 |
| 2015 | 1 | 92 |
| 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 |
|---|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | 13 | 13 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 7 | 7 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 7 | 7 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 5 | 5 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 3 | 3 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 2 | 2 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 2 | 2 |
| DWE | Tubing, Pump, Cardiopulmonary Bypass | 2 | 2 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 1 | 1 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Maquet Cardiopulmonary, AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150267 | QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators | DTZ | 2015-05-07 | 92 |
| K140569 | ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE) | DWF | 2014-11-19 | 258 |
| K141432 | NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH | DTN | 2014-07-07 | 38 |
| K133598 | CARDIOHELP SYSTEM | DTQ | 2014-05-21 | 180 |
| K133265 | QUADROX-IR ADULT AND SMALL ADULT | KFM | 2013-11-12 | 20 |
| K132166 | VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT | DTN | 2013-10-30 | 110 |
| K132829 | QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS | DTZ | 2013-10-08 | 29 |
| K131666 | ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING | DWF | 2013-07-05 | 28 |
| K130300 | HEATER-COOLER UNIT HCU 40 | DWC | 2013-07-01 | 144 |
| K123288 | HEMOCONCENTRATOR | KDI | 2013-06-26 | 247 |
34 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 3 recall events; 1 initiated in the last five years. Most recent: 2025-04-30.
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.
- Maquet Critical Care AB (20 510(k)s)
- Maquet Cardiovascular, LLC (14 510(k)s)
- Maquet GmbH (4 510(k)s)
- Maquet S.A.S. (2 510(k)s)
- Maquet Critica Care AB (1 510(k)s)
- Maquet GmbH (A Getinge Group Company) (1 510(k)s)
- Maquet GmbH and Co. KG (1 510(k)s)
- Maquet S.A. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Maquet Cardiopulmonary, AG?
FDA lists 44 510(k) clearances under the applicant name “Maquet Cardiopulmonary, AG” (first 2005, latest 2015), across 11 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Maquet Cardiopulmonary, AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Maquet Cardiopulmonary, AG is 138 days.
Which FDA product codes appear under Maquet Cardiopulmonary, AG?
The most frequent FDA product codes under this applicant name are DTZ (Oxygenator, Cardiopulmonary Bypass, 13); DTN (Reservoir, Blood, Cardiopulmonary Bypass, 7); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 7).
Next steps
- See all 44 Maquet Cardiopulmonary, AG clearances with predicates and recalls
- Run predicate analysis for product code DTZ, Maquet Cardiopulmonary, AG'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.