Class Class II
SKOUT system (K251126)
Description
SKOUT system by Iterative Health, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251126
Clearance Date2025-05-09
Clearance TypeSpecial
Product CodeQNP
Regulation Number876.1520
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251126
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. SKOUT system (K251126) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241508 | SKOUT® system | Iterative Scopes, Inc. | 2024 |
| K240781 | SKOUT® system | Iterative Scopes, Inc. | 2024 |
| K213686 | SKOUT Software | Iterative Scopes, Inc. | 2022 |
Trace the full predicate network for K251126
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.