FDA product code DKO: Adsorbents, Ion-Exchange
DKO is the FDA product code for adsorbents, ion-exchange. It is a Class I device, regulated under 21 CFR 862.2230 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DKO. The average 510(k) review took 56 days (median 56).
Classification
| Field | Value |
|---|---|
| Device name | Adsorbents, 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 DKO clearance
Top DKO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Molecular Biosystems, Inc. | 1 | 1987-11-20 |
Most recent DKO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K873932 | Molecular Biosystems, Inc. | THE EXTRACTOR(TM) | 1987-11-20 | 56 |
Recalls for DKO devices
openFDA lists no recalls for product code DKO.
Frequently asked questions
What is FDA product code DKO?
DKO is the FDA product code for adsorbents, 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 DKO?
Class I, regulation 21 CFR 862.2230. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DKO?
Across 1 cleared submissions the average was 56 days from receipt to decision (median 56).
Which companies have the most DKO clearances?
Molecular Biosystems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DKO
- Run a recall and safety report across every DKO manufacturer
- Watch product code DKO 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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