Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Abiomed, Inc. · Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
105 daysmedian FDA review time
422 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252766 | 14Fr Low Profile Introducer Kit | Abiomed, Inc. | 2025-10-08 | 40 | 0 |
| K241708 | Abiomed 14Fr Low Profile Introducer Kit | Abiomed, Inc. | 2024-08-06 | 54 | 4 |
| K221294 | preCARDIA Occlusion System | Abiomed, Inc. | 2023-06-30 | 422 | 0 |
| K223161 | OXY-1 System | Abiomed, Inc. | 2023-02-23 | 139 | 0 |
| K222113 | Abiomed 14Fr Low Profile Introducer Set | Abiomed, Inc. | 2022-10-13 | 87 | 1 |
| K202330 | Impella XR Sheath Set | Abiomed, Inc. | 2020-12-07 | 112 | 0 |
| K200109 | OXY-1 System | Abiomed, Inc. | 2020-10-23 | 280 | 1 |
| K201116 | Abiomed 23 Fr Sheath | Abiomed, Inc. | 2020-06-15 | 49 | 13 |
| K192769 | Impella CP Introducer | Abiomed, Inc. | 2019-11-18 | 49 | 20 |
| K112892 | IMPELLA 2.5 PLUS CATHETER | Abiomed, Inc. | 2012-09-06 | 342 | 0 |
| K110845 | IMPELLA CONTROLLER WITH FLOW CONTROL | Abiomed, Inc. | 2011-04-27 | 30 | 0 |
| K093801 | IMPELLA CONTROLLER | Abiomed, Inc. | 2010-07-08 | 210 | 0 |
| K083111 | IMPELLA 5.0 CATHETER FAMILY | Abiomed, Inc. | 2009-04-16 | 177 | 1 |
| K063723 | IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM | Abiomed, Inc. | 2008-05-30 | 532 | 0 |
| K070225 | SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE | Abiomed, Inc. | 2007-12-13 | 323 | 0 |
| K062582 | SUPRACOR BALLOON CATHETER | Abiomed, Inc. | 2006-12-14 | 105 | 0 |
| K911643 | ABIODENT PERIOTEMP(R) SYSTEM | Abiomed, Inc. | 1991-07-09 | 88 | 0 |
| K900574 | ABIOMED BODY LEAD ANALYZER MODEL 200/20 | Abiomed, Inc. | 1990-03-15 | 36 | 0 |
| K885075 | ABIOMED PERIOTEMP(TM) PROBE | Abiomed, Inc. | 1989-02-13 | 67 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda