Class Class II
Perifit (K221476)
Description
Perifit by X6 Innovations, an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221476
Clearance Date2023-02-10
Clearance TypeTraditional
Product CodeHIR
Regulation Number884.1425
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221476
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. Perifit (K221476) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K160758 | PeriCoach OTC | Analytica, Ltd. | 2016 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231780 | Perifit Care+ | X6 Innovations | 2023 |
Trace the full predicate network for K221476
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.