# Phenox Limited

- Location (FDA's records): Galway, IE
- FDA decisions: 7 (2019–2026): 7 510(k) clearances
- Names in FDA's records: Phenox Limited (4); Phenox, Ltd. (3)
- Product codes: POL (3), DQO (2), NRY (1), DQX (1)
- 510(k) review time since 2016: median 133 days, against 148 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 8 (4 its own); citations of its devices by later devices: 4 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Wallaby Medical: 1 (https://510kreport.com/company/wallaby-medical)
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular: 1 (https://510kreport.com/company/micro-therapeutics-d-b-a-ev3-neurovascular)
- MicroVention, Inc.: 1 (https://510kreport.com/company/microvention)
- Scimed Peripheral Interventions: 1 (https://510kreport.com/company/scimed-peripheral-interventions)

## Its most-cited devices
- K222848: pRESET Thrombectomy Device (2023), cited by 2
- K221279: pNOVUS 21 Microcatheter (2022), cited by 1
- K231539: pRESET LITE Thrombectomy Device (2023), cited by 1

## Recent decisions
- K251357: Esperance pHLO Aspiration System (Jan 15, 2026)
- K242676: pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device (Feb 28, 2025)
- K242420: pNOVUS 21 Microcatheter (Nov 12, 2024)
- K231539: pRESET LITE Thrombectomy Device (Oct 21, 2023)
- K222848: pRESET Thrombectomy Device (Jan 20, 2023)
- K221279: pNOVUS 21 Microcatheter (Nov 28, 2022)
- K191687: pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire (Oct 9, 2019)

Source page: https://510kreport.com/company/phenox