510(k) Report

FDA applicant

Wallaby Medical

Laguna Hills, CA8 decisions2018–20260 recalls

FDA records 8 decisions for Wallaby Medical (Laguna Hills, CA) from 2018 to 2026: 8 510(k) clearances. Most are in product codes NRY (Catheter, Thrombus Retriever) and DQY (Catheter, Percutaneous). Since 2016 its 510(k)s took a median of 183 days from receipt to decision, against 128 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Wallaby Medical, Inc.”.

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 Wallaby Medical’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2018: 12021: 12023: 32024: 22026 (partial year): 1
2018high 3 (2023) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Wallaby Medical by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Wallaby Medical’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?

  • NRYCatheter, Thrombus Retriever2decisions
  • DQYCatheter, Percutaneous2decisions
  • QJPCatheter, Percutaneous, Neurovasculature2decisions
  • HCGDevice, Neurovascular Embolization1decision
  • KRACatheter, Continuous Flush1decision

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 183 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 128 days; 2 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K211697Esperance Aspiration Catheter SystemWallaby Medical · 20211cites it

What has FDA decided for it lately?

  • K254071p17 XR MicrocatheterWallaby Medical · 2026
  • K240917Esperance 3+ Aspiration Catheter SystemWallaby Medical · 2024
  • K231056Esperance Distal Access CatheterWallaby Medical · 2024
  • K232437Paragon 8F Balloon Guide CatheterWallaby Medical · 2023
  • K223139Wallaby 017 Micro CatheterWallaby Medical · 2023
  • K2226036F Wallaby Long SheathWallaby Medical, Inc. · 2023
  • K211697Esperance Aspiration Catheter SystemWallaby Medical · 2021
  • K173711Wallaby Avenir Coil SystemWallaby Medical, Inc. · 2018

All 6 as Wallaby Medical →All 2 as Wallaby Medical, Inc. →