Class Class II
ASEPT Peritoneal Drainage System (K221779)
Description
ASEPT Peritoneal Drainage System by Pfm Medical, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221779
Clearance Date2023-05-02
Clearance TypeTraditional
Product CodePNG
Regulation Number876.5630
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221779
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. ASEPT Peritoneal Drainage System (K221779) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201155 | PleurX Peritoneal Catheter System | Care Fusion | 2020 |
| K093796 | ASEPT PERITONEAL DRAINAGE SYSTEM | Pfm Medical, Inc. | 2010 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241278 | ASEPT® Glide Peritoneal Drainage System | Pfm Medical, Inc. | 2025 |
Trace the full predicate network for K221779
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.