Abiomed, Inc.: FDA clearances and approvals
Abiomed, Inc. has 19 FDA 510(k) clearances (first 1989, latest 2025), plus 2 PMA decisions, across 10 product codes in 3 review panels. Median 510(k) review time: 105 days. Since 2017 its median was 87 days, against 78 days for all cleared 510(k)s in the same product codes. openFDA lists 90 product recalls by a recalling firm named Abiomed, Inc. It is the industry lead sponsor of 19 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 342 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 49 |
| 2020 | 3 | 112 |
| 2021 | 0 | — |
| 2022 | 1 | 87 |
| 2023 | 2 | 280 |
| 2024 | 1 | 54 |
| 2025 | 1 | 40 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Abiomed, Inc.'s cleared 510(k)s took a median 87 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 78 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYB | Introducer, Catheter | 6 | 6 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 4 | 4 |
| DSP | System, Balloon, Intra-Aortic And Control | 2 | 2 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 2 | 2 |
| EIL | Gauge, Depth, Instrument, Dental | 2 | 2 |
| JAO | Scanner, Fluorescent | 1 | 1 |
| MJN | Catheter, Intravascular Occluding, Temporary | 1 | 1 |
| OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | 1 | 0 |
| PBL | 1 | 1 | |
| PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | 1 | 0 |
Review panels
- Cardiovascular (17)
- Dental (2)
- Radiology (1)
Most recent Abiomed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252766 | 14Fr Low Profile Introducer Kit | DYB | 2025-10-08 | 40 |
| K241708 | Abiomed 14Fr Low Profile Introducer Kit | DYB | 2024-08-06 | 54 |
| K221294 | preCARDIA Occlusion System | MJN | 2023-06-30 | 422 |
| K223161 | OXY-1 System | DTZ | 2023-02-23 | 139 |
| K222113 | Abiomed 14Fr Low Profile Introducer Set | DYB | 2022-10-13 | 87 |
| K202330 | Impella XR Sheath Set | DYB | 2020-12-07 | 112 |
| K200109 | OXY-1 System | DTZ | 2020-10-23 | 280 |
| K201116 | Abiomed 23 Fr Sheath | DYB | 2020-06-15 | 49 |
| K192769 | Impella CP Introducer | DYB | 2019-11-18 | 49 |
| K112892 | IMPELLA 2.5 PLUS CATHETER | PBL | 2012-09-06 | 342 |
9 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P170011 | PMA | Impella RP System | 2017-09-20 |
| P140003 | PMA | IMPELLA 2.5 System | 2015-03-23 |
Recalls
90 product recalls in 38 recall events; 79 initiated in the last five years. Most recent: 2026-08-12.
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.
Device clinical trials
Abiomed, Inc. is the industry lead sponsor of 19 device studies on ClinicalTrials.gov (10 active or recruiting). Most recent:
- NCT06964685: Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock (Recruiting, started 2025-07-10)
- NCT06637644: Impella RP Flex with Smart Assist (Recruiting, started 2024-05-29)
- NCT05759377: V-A ECMO AUTO Mode Registry (Completed, started 2023-10-11)
- NCT05529654: IMpella-Protected cArdiaC Surgery Trial (IMPACT) (Active not recruiting, started 2023-09-21)
- NCT05756751: IMPACT EU Post-Market Clinical Follow-Up Study (Active not recruiting, started 2023-04-27)
Frequently asked questions
How many FDA 510(k) clearances does Abiomed, Inc. have?
Abiomed, Inc. has 19 FDA 510(k) clearances (first 1989, latest 2025), plus 2 PMA decisions, across 10 product codes in 3 review panels.
How long does FDA take to clear Abiomed, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Abiomed, Inc.'s cleared 510(k)s is 105 days. Since 2017: 87 days, versus 78 days for all cleared 510(k)s in the same product codes.
What devices does Abiomed, Inc. make?
Its most frequent FDA product codes are DYB (Introducer, Catheter, 6); KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type, 4); DSP (System, Balloon, Intra-Aortic And Control, 2).
Has Abiomed, Inc. had device recalls?
openFDA lists 90 product recalls in 38 recall events by a recalling firm whose name matches Abiomed, Inc; the most recent began 2026-08-12. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 19 Abiomed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DYB, Abiomed, Inc.'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.