FKNClass II

Adaptor, Shunt

21 CFR 876.5540 / Gastroenterology, Urology

FKN is the FDA product code for Adaptor, Shunt, a class II device type, regulated under 21 CFR 876.5540. As of 2026-09-10, FDA records hold 4 510(k) clearances under this code, the most recent dated 1989-06-08, and no recalls.

Classification record

Product code: FKN
Device name: Adaptor, Shunt
Regulation: 21 CFR 876.5540
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 4
Ingested recalls: 0

Clearances, product code FKN

By decision year

4 clearances under product code FKN with a decision year between 1978 and 1989, 1989 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code FKN by decision year
Year	Clearances
1978	1
1981	1
1989	2

Applicants with the most clearances

Product code FKN

Applicants holding the most 510(k) clearances under product code FKN
Applicant	Clearances
Akcess Medical Products, Inc.	2
Quinton, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

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

Recent clearances

Product code FKN

Recent recalls

Product code FKN

FDA records show no recalls under product code FKN.

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)