510(k) Report

FDA applicant

Rist Neurovascular, Inc.

Miramar, FL3 decisions2019–20200 recalls

FDA records 3 decisions for Rist Neurovascular, Inc. (Miramar, FL) from 2019 to 2020: 3 510(k) clearances. Most are in product codes QJP (Catheter, Percutaneous, Neurovasculature) and DQY (Catheter, Percutaneous). Since 2016 its 510(k)s took a median of 98 days from receipt to decision, against 72 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 of them its own earlier devices. No 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 Rist Neurovascular, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2019: 12020: 2
2019high 2 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Rist Neurovascular, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Rist Neurovascular, 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?

  • QJPCatheter, Percutaneous, Neurovasculature2decisions
  • DQYCatheter, Percutaneous1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 98 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 72 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K191551RIST Cath Radial Access Long SheathRist Neurovascular, Inc. · 20193cite it
  • K201682RIST Radial Access CatheterRist Neurovascular, Inc. · 20201cites it
  • K200417RIST Radial Access CatheterRist Neurovascular, Inc. · 20201cites it

What has FDA decided for it lately?

  • K201682RIST Radial Access CatheterRist Neurovascular, Inc. · 2020
  • K200417RIST Radial Access CatheterRist Neurovascular, Inc. · 2020
  • K191551RIST Cath Radial Access Long SheathRist Neurovascular, Inc. · 2019

All 3 as Rist Neurovascular, Inc. →