KEAClass I

Resins, Ion-Exchange

21 CFR 862.2230 / Clinical Chemistry

KEA is the FDA product code for Resins, Ion-Exchange, a class I device type, regulated under 21 CFR 862.2230. As of 2026-09-10, FDA records hold 9 510(k) clearances under this code, the most recent dated 1989-03-28, and no recalls.

Classification record

Product code: KEA
Device name: Resins, Ion-Exchange
Regulation: 21 CFR 862.2230
Device class: Class I
Review panel: Clinical Chemistry
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 9
Ingested recalls: 0

Clearances, product code KEA

By decision year

9 clearances under product code KEA with a decision year between 1978 and 1989, 1983 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code KEA by decision year
Year	Clearances
1978	1
1979	1
1983	4
1984	1
1985	1
1989	1

Applicants with the most clearances

Product code KEA

Applicants holding the most 510(k) clearances under product code KEA
Applicant	Clearances
Biosan Laboratories, Inc.	2
Analytichem International, Inc.	1
Atlantic Wholesale, Inc.	1
Berwick Medical Products, Inc.	1
EMD Millipore Corporation	1
Lkb Instruments, Inc.	1
Mcb Manufacturing Chemists, Inc.	1
Syva Co.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

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