510(k) Report

FDA applicant

Inneuroco, Inc.

Sunrise, FL9 decisions2016–20233 recalls

FDA records 9 decisions for Inneuroco, Inc. (Sunrise, FL) from 2016 to 2023: 9 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and NRY (Catheter, Thrombus Retriever). Since 2016 its 510(k)s took a median of 137 days from receipt to decision, against 113 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 2 of them its own earlier devices. 3 recalls are 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 Inneuroco, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2016: 12017: 22018: 32019: 12022: 12023: 1
2016high 3 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

3in 2019

2019: 3
2016high 3 (2019) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Inneuroco, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DQYCatheter, Percutaneous5decisions
  • NRYCatheter, Thrombus Retriever3decisions
  • DYBIntroducer, Catheter1decision

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 137 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 113 days; 1 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 2 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.

  • K190338046 Zenith FlexInneuroco, Inc. · 20192cite it
  • K171672065 Zenith, 074 ZenithInneuroco, Inc. · 20171cites it
  • K220331091 Balloon Guide CatheterInneuroco, Inc. · 20221cites it
  • K172468091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cmInneuroco, Inc. · 20171cites it
  • K232260Thinline Sheath IntroducerInneuroco, Inc. · 20231cites it
  • K181354074 Zenith Flex SystemInneuroco, Inc. · 20181cites it

What has FDA decided for it lately?

  • K232260Thinline Sheath IntroducerInneuroco, Inc. · 2023
  • K220331091 Balloon Guide CatheterInneuroco, Inc. · 2022
  • K190338046 Zenith FlexInneuroco, Inc. · 2019
  • K181354074 Zenith Flex SystemInneuroco, Inc. · 20181 recall
  • K172167Zenith Flex SystemInneuroco, Inc. · 20181 recall
  • K173709Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cmInneuroco, Inc. · 2018
  • K172468091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cmInneuroco, Inc. · 20171 recall
  • K171672065 Zenith, 074 ZenithInneuroco, Inc. · 2017

All 9 as Inneuroco, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K172468Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA…Apr 18, 2019Class II
  • K172167Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115…Apr 10, 2019Class II
  • K181354Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-115…Apr 10, 2019Class II