FDA product code KDX: Solution, Decalcifier, Acid Containing
KDX is the FDA product code for solution, decalcifier, acid containing. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 8 510(k) submissions under KDX, from 8 different applicants. The average 510(k) review took 26 days (median 25).
Classification
| Field | Value |
|---|---|
| Device name | Solution, Decalcifier, Acid Containing |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KDX clearance
Top KDX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stephens Scientific | 1 | 1987-08-06 |
| Fisher Scientific Co., LLC | 1 | 1985-03-20 |
| E K Ind., Inc. | 1 | 1984-08-03 |
| Surgipath Medical Industries, Inc. | 1 | 1984-05-02 |
| Volu Sol Medical Industries | 1 | 1982-08-03 |
3 more applicants have KDX clearances. See the full list in Caduvo.
Most recent KDX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K872625 | Stephens Scientific | DECALCIFYING SOLUTION | 1987-08-06 | 31 |
| K850636 | Fisher Scientific Co., LLC | SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E | 1985-03-20 | 29 |
| K842726 | E K Ind., Inc. | DECALCIFIER SOLUTION | 1984-08-03 | 21 |
| K841488 | Surgipath Medical Industries, Inc. | DECALCIFIER I | 1984-05-02 | 22 |
| K822036 | Volu Sol Medical Industries | VOLU-SOL DECALCIFER | 1982-08-03 | 22 |
Recalls for KDX devices
openFDA lists no recalls for product code KDX.
Frequently asked questions
What is FDA product code KDX?
KDX is the FDA product code for solution, decalcifier, acid containing. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is KDX?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KDX?
Across 8 cleared submissions the average was 26 days from receipt to decision (median 25).
Which companies have the most KDX clearances?
Stephens Scientific (1); Fisher Scientific Co., LLC (1); E K Ind., Inc. (1); Surgipath Medical Industries, Inc. (1); Volu Sol Medical Industries (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KDX
- Run a recall and safety report across every KDX manufacturer
- Watch product code KDX 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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