Class Class II
pRESET Thrombectomy Device (K222848)
Description
pRESET Thrombectomy Device by Phenox Limited, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222848
Clearance Date2023-01-20
Clearance TypeTraditional
Product CodePOL
Regulation Number882.5600
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222848
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. pRESET Thrombectomy Device (K222848) cites 1 predicate device and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K162539 | Solitaire 2 Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 ... | 2016 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242676 | pRESET Delta Thrombectomy Device and pRESET Delta LITE Thro... | Phenox Limited | 2025 |
| K231539 | pRESET LITE Thrombectomy Device | Phenox Limited | 2023 |
Trace the full predicate network for K222848
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.