KJHClass I

Apparatus, Perfusion

21 CFR 864.2240 / Hematology

KJH is the FDA product code for Apparatus, Perfusion, a class I device type, regulated under 21 CFR 864.2240. As of 2026-09-10, FDA records hold 3 510(k) clearances under this code, the most recent dated 1988-01-12, and no recalls.

Classification record

Product code: KJH
Device name: Apparatus, Perfusion
Regulation: 21 CFR 864.2240
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: 3
Ingested recalls: 0

Clearances, product code KJH

By decision year

3 clearances under product code KJH with a decision year between 1986 and 1988, 1986 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code KJH by decision year
Year	Clearances
1986	1
1987	1
1988	1

Applicants with the most clearances

Product code KJH

Applicants holding the most 510(k) clearances under product code KJH
Applicant	Clearances
Endotronics, Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

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

Recent clearances

Product code KJH

Recent recalls

Product code KJH

FDA records show no recalls under product code KJH.

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)