510(k) Report

FDA applicant

LimFlow, Inc.

San Jose, CA7 decisions2022–20261 recall

FDA records 7 decisions for LimFlow, Inc. (San Jose, CA) from 2022 to 2026: 6 510(k) clearances and 1 original PMA approval. Most are in product codes MGZ (Valvulotome) and MMX (Device, Percutaneous Retrieval). Since 2016 its 510(k)s took a median of 29 days from receipt to decision, against 139 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.

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 LimFlow, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2022: 32023: 12025: 22026 (partial year): 1
2022high 3 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2022high 1 (2025) · low 0 (2022)2026

Class I Class II/III not classified

FIG. 1 — LimFlow, Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • MGZValvulotome2decisions
  • MMXDevice, Percutaneous Retrieval2decisions
  • PDUCatheter For Crossing Total Occlusions2decisions
  • QWNStent Graft, Infrapopliteal, Venous Arterialization1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 29 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 139 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K221902LimFlow VectorLimFlow, Inc. · 20221cites it
  • K222083LimFlow V-CeiverLimFlow, Inc. · 20221cites it
  • K221541LimFlow ARCLimFlow, Inc. · 20221cites it

What has FDA decided for it lately?

  • K260188LimFlow VectorLimFlow, Inc. · 2026
  • K251376LimFlow ARCLimFlow, Inc. · 2025
  • K242776LimFlow V-CeiverLimFlow, Inc. · 2025
  • P220025LimFlow SystemLimFlow, Inc. · 2023
  • K221902LimFlow VectorLimFlow, Inc. · 20221 recall
  • K221541LimFlow ARCLimFlow, Inc. · 2022
  • K222083LimFlow V-CeiverLimFlow, Inc. · 2022

All 7 as LimFlow, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K221902Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23Dec 5, 2025Class II