510(k) Report

FDA applicant

Phenox Limited

Galway, IE7 decisions2019–20260 recalls

FDA records 7 decisions for Phenox Limited (Galway, IE) from 2019 to 2026: 7 510(k) clearances. Most are in product codes POL (Neurovascular Mechanical Thrombectomy Device…) and DQO (Catheter, Intravascular, Diagnostic). Since 2016 its 510(k)s took a median of 133 days from receipt to decision, against 148 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Phenox, Ltd.”.

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 Phenox Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019: 12022: 12023: 22024: 12025: 12026 (partial year): 1
2019high 2 (2023) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

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

Planning a device like Phenox Limited’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?

  • POLNeurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment3decisions
  • DQOCatheter, Intravascular, Diagnostic2decisions
  • NRYCatheter, Thrombus Retriever1decision
  • DQXWire, Guide, Catheter1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 133 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 148 days; 3 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 4 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.

  • K222848pRESET Thrombectomy DevicePhenox Limited · 20232cite it
  • K221279pNOVUS 21 MicrocatheterPhenox, Ltd. · 20221cites it
  • K231539pRESET LITE Thrombectomy DevicePhenox Limited · 20231cites it

What has FDA decided for it lately?

  • K251357Esperance pHLO Aspiration SystemPhenox, Ltd. · 2026
  • K242676pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy DevicePhenox Limited · 2025
  • K242420pNOVUS 21 MicrocatheterPhenox, Ltd. · 2024
  • K231539pRESET LITE Thrombectomy DevicePhenox Limited · 2023
  • K222848pRESET Thrombectomy DevicePhenox Limited · 2023
  • K221279pNOVUS 21 MicrocatheterPhenox, Ltd. · 2022
  • K191687pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension WirePhenox Limited · 2019

All 4 as Phenox Limited →All 3 as Phenox, Ltd. →