510(k) Report

FDA applicant

Abiomed, Inc.

Danvers, MA21 decisions1989–202557 recalls

FDA records 21 decisions for Abiomed, Inc. (Danvers, MA) from 1989 to 2025: 19 510(k) clearances and 2 original PMA approvals. Most are in product codes DYB (Introducer, Catheter) and KFM (Pump, Blood, Cardiopulmonary Bypass…). Since 2016 its 510(k)s took a median of 71 days from receipt to decision, against 60 for FDA’s reviews in the same codes and years. Its devices cite 30 predicates, 7 of them its own earlier devices. 57 recalls are linked to its devices, 38 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Abiomed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 12008: 12009: 12010: 12011: 12012: 12015: 12017: 12019: 12020: 32022: 12023: 22024: 12025: 1
2007high 3 (2020) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

31in 2026

2010: 12011: 1, 1 Class I2019: 22021: 2, 1 Class I2023: 13, 2 Class I2024: 3, 3 Class I2025: 4, 3 Class I2026 (partial year): 31, 28 Class I
2007high 31 (2026) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Abiomed, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Abiomed, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DYBIntroducer, Catheter6decisions
  • KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type4decisions
  • EILGauge, Depth, Instrument, Dental2decisions
  • DTZOxygenator, Cardiopulmonary Bypass2decisions
  • DSPSystem, Balloon, Intra-Aortic And Control2decisions
  • OZDTemporary Non-Roller Type Left Heart Support Blood Pump1decision

Also: PYX (1), MJN (1), PBL (1), JAO (1).

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 71 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 60 days; 4 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 30 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K063723Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc. · 20083cite it
  • K200109OXY-1 SystemAbiomed, Inc. · 20202cite it
  • K083111Impella 5.0 Catheter FamilyAbiomed, Inc. · 20091cites it
  • K241708Abiomed 14Fr Low Profile Introducer KitAbiomed, Inc. · 20241cites it
  • K093801Impella ControllerAbiomed, Inc. · 20101cites it
  • K062582Supracor Balloon CatheterAbiomed, Inc. · 20061cites it

What has FDA decided for it lately?

  • K25276614Fr Low Profile Introducer KitAbiomed, Inc. · 2025
  • K241708Abiomed 14Fr Low Profile Introducer KitAbiomed, Inc. · 20244 Class I recalls
  • K221294preCARDIA Occlusion SystemAbiomed, Inc. · 2023
  • K223161OXY-1 SystemAbiomed, Inc. · 2023
  • K222113Abiomed 14Fr Low Profile Introducer SetAbiomed, Inc. · 20221 recall
  • K202330Impella XR Sheath SetAbiomed, Inc. · 2020
  • K200109OXY-1 SystemAbiomed, Inc. · 20201 Class I recall
  • K201116Abiomed 23 Fr SheathAbiomed, Inc. · 202013 Class I recalls

All 21 as Abiomed, Inc. →

What has been recalled?

57 recalls linked to its devices; the latest:

  • P140003Automated Impella Controller, Packaged. Primary user control interface for the Impella…Sep 18, 2026
  • P140003Impella Optical Controller, Packaged. Primary user control interface for the Impella…Sep 18, 2026
  • P140003Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella…Sep 18, 2026
  • P140003Impella Optical Controller with the below product descriptions and corresponding Product…Aug 12, 2026Class I
  • P140003Automated Impella Controller (AIC) with the below product descriptions and corresponding…Aug 12, 2026Class I
  • P140003Impella Optical Controller, Automated Impella Controller, Impella Connect Package with…Aug 12, 2026Class I

Other applicant names beginning “Abiomed”

FDA records each applicant name separately; these may or may not be the same firm.

Abiomed Cardiovascular, Inc. 1