FDA product code KEA: Resins, Ion-Exchange
KEA is the FDA product code for resins, ion-exchange. It is a Class I device, regulated under 21 CFR 862.2230 and reviewed by the Clinical Toxicology panel. FDA has cleared 9 510(k) submissions under KEA, from 8 different applicants. The average 510(k) review took 66 days (median 38).
Classification
| Field | Value |
|---|---|
| Device name | Resins, Ion-Exchange |
| Device class | Class I |
| Regulation | 21 CFR 862.2230 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KEA clearance
Top KEA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biosan Laboratories, Inc. | 2 | 1983-12-08 |
| Atlantic Wholesale, Inc. | 1 | 1989-03-28 |
| Syva Co. | 1 | 1985-08-29 |
| Lkb Instruments, Inc. | 1 | 1984-06-07 |
| Emd Chemicals, Inc. | 1 | 1983-05-16 |
3 more applicants have KEA clearances. See the full list in Caduvo.
Most recent KEA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890997 | Atlantic Wholesale, Inc. | ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) | 1989-03-28 | 29 |
| K844948 | Syva Co. | SYVA SOLID PHASE COLUMNS | 1985-08-29 | 252 |
| K842028 | Lkb Instruments, Inc. | CM-TRISACRYL M DEAE-TRISACRYL M | 1984-06-07 | 20 |
| K833320 | Biosan Laboratories, Inc. | AMBERLITE CG50 RESIN, 100-200 MESH | 1983-12-08 | 73 |
| K833319 | Biosan Laboratories, Inc. | BIO-REX 70 RESIN 100-200 MESH PH6.2 | 1983-11-03 | 38 |
Recalls for KEA devices
openFDA lists no recalls for product code KEA.
Frequently asked questions
What is FDA product code KEA?
KEA is the FDA product code for resins, ion-exchange. It is a Class I device, regulated under 21 CFR 862.2230 and reviewed by the Clinical Toxicology panel.
What device class is KEA?
Class I, regulation 21 CFR 862.2230. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KEA?
Across 9 cleared submissions the average was 66 days from receipt to decision (median 38).
Which companies have the most KEA clearances?
Biosan Laboratories, Inc. (2); Atlantic Wholesale, Inc. (1); Syva Co. (1); Lkb Instruments, Inc. (1); Emd Chemicals, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KEA
- Run a recall and safety report across every KEA manufacturer
- Watch product code KEA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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