KYSClass I

Insoles, Medical

21 CFR 880.6280 / General Hospital

KYS is the FDA product code for Insoles, Medical, a class I device type, regulated under 21 CFR 880.6280. As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 1978-10-10, and no recalls.

Classification record

Product code: KYS
Device name: Insoles, Medical
Regulation: 21 CFR 880.6280
Device class: Class I
Review panel: General Hospital
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code KYS

By decision year

1 clearance under product code KYS with a decision year between 1978 and 1978, 1978 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code KYS by decision year
Year	Clearances
1978	1

Applicants with the most clearances

Product code KYS

Applicants holding the most 510(k) clearances under product code KYS
Applicant	Clearances
Combe, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 120 companies shown, in name order

Recent clearances

Product code KYS

K780719Class IFungus Fighter InsolesCombe, Inc. / cleared 1978-10-10

Recent recalls

Product code KYS

FDA records show no recalls under product code KYS.

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)