KFDClass I

Aniline Blue

21 CFR 864.1850 / Hematology

KFD is the FDA product code for Aniline Blue, a class I device type, regulated under 21 CFR 864.1850. As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 1989-07-25, and no recalls.

Classification record

Product code: KFD
Device name: Aniline Blue
Regulation: 21 CFR 864.1850
Device class: Class I
Review panel: Hematology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code KFD

By decision year

1 clearance under product code KFD with a decision year between 1989 and 1989, 1989 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code KFD by decision year
Year	Clearances
1989	1

Applicants with the most clearances

Product code KFD

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

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order

Recent clearances

Product code KFD

K894045Class IModified Polychrome IV StainDevetec, Inc. / cleared 1989-07-25

Recent recalls

Product code KFD

FDA records show no recalls under product code KFD.

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)