PKIClass II

Fully Subcutaneous Implanted Hemodialysis Catheter

21 CFR 876.5540 / Gastroenterology, Urology

PKI is the FDA product code for Fully Subcutaneous Implanted Hemodialysis Catheter, a class II device type, regulated under 21 CFR 876.5540. FDA's definition for this code reads: "Provides access to the blood for hemodialysis or other chronic uses". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PKI
Device name: Fully Subcutaneous Implanted Hemodialysis Catheter
FDA definition: Provides access to the blood for hemodialysis or other chronic uses.
Regulation: 21 CFR 876.5540
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code PKI.

Recent clearances

Product code PKI

FDA records hold no clearances under product code PKI.

Recent recalls

Product code PKI

FDA records show no recalls under product code PKI.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)