Maquet Critical Care AB: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Maquet Critical Care AB” (first 2004, latest 2026), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 190 days. Since 2017 the median was 355 days, against 204 days for all cleared 510(k)s in the same product codes. 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 | 1 | 172 |
| 2013 | 0 | — |
| 2014 | 2 | 354 |
| 2015 | 2 | 89 |
| 2016 | 0 | — |
| 2017 | 2 | 410 |
| 2018 | 0 | — |
| 2019 | 2 | 401 |
| 2020 | 1 | 335 |
| 2021 | 1 | 287 |
| 2022 | 0 | — |
| 2023 | 1 | 167 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 275 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Maquet Critical Care AB took a median 355 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 204 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 9 | 9 |
| BSZ | Gas-Machine, Anesthesia | 5 | 5 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 | 2 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | 2 | 2 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| MNT | Sv70 Ventilator | 1 | 1 |
Review panels
Most recent Maquet Critical Care AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253715 | Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279) | PIF | 2026-08-26 | 275 |
| K230173 | Servo-air Lite Ventilator System | MNT | 2023-07-06 | 167 |
| K201874 | Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 | CBK | 2021-04-20 | 287 |
| K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System | BSZ | 2020-03-18 | 335 |
| K182862 | Servo Guard | CAH | 2019-10-21 | 375 |
| K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 | CBK | 2019-03-19 | 427 |
| K160665 | FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 | BSZ | 2017-03-29 | 385 |
| K153688 | Edi Catheter ENFit | PIF | 2017-03-02 | 435 |
| K151814 | SERVO-U Ventilator System, SERVO-n Ventilator System | CBK | 2015-12-21 | 168 |
| K153461 | Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm | KNT | 2015-12-11 | 10 |
10 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 3 recall events; 5 initiated in the last five years. Most recent: 2026-06-30.
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.
Device clinical trials
An industry sponsor named Maquet Critical Care AB is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06114992: Servo-n HFOV Study: Safety and Performance in Neonates and Infants (Active not recruiting, started 2024-07-15)
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 Cardiopulmonary, AG (44 510(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 Critical Care AB?
FDA lists 20 510(k) clearances under the applicant name “Maquet Critical Care AB” (first 2004, latest 2026), across 6 product codes in 3 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 Critical Care AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Maquet Critical Care AB is 190 days. Since 2017: 355 days, versus 204 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Maquet Critical Care AB?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 9); BSZ (Gas-Machine, Anesthesia, 5); KNT (Tubes, Gastrointestinal (And Accessories), 2).
Next steps
- See all 20 Maquet Critical Care AB clearances with predicates and recalls
- Run predicate analysis for product code CBK, Maquet Critical Care AB'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.