Class Class II
PENTAX Medical Video Processor (EPK-i8020c) (K251127)
Description
PENTAX Medical Video Processor (EPK-i8020c) by Pentax of America, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251127
Clearance Date2025-06-03
Clearance TypeTraditional
Product CodePEA
Regulation Number876.1500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251127
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. PENTAX Medical Video Processor (EPK-i8020c) (K251127) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232860 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical V... | Pentax of America, Inc. | 2024 |
| K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical V... | Pentax of America, Inc. | 2023 |
Trace the full predicate network for K251127
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.