FDA product code KXM: System Accessories, Extracorporeal
KXM is the FDA product code for system accessories, extracorporeal. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 4 510(k) submissions under KXM, from 4 different applicants. The average 510(k) review took 271 days (median 76).
Classification
| Field | Value |
|---|---|
| Device name | System Accessories, Extracorporeal |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every KXM clearance
Top KXM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Baxter Healthcare Corp | 1 | 1995-05-03 |
| Colorado Medical, Inc. | 1 | 1986-10-02 |
| Cp Medical | 1 | 1985-10-17 |
| Parker Hannifin Corp. | 1 | 1983-08-08 |
Most recent KXM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K925581 | Baxter Healthcare Corp | BAXTER BIOSTAT 1000 UREA MONITOR | 1995-05-03 | 909 |
| K863471 | Colorado Medical, Inc. | COLORADO MEDICAL MODEL PTC 1000 | 1986-10-02 | 23 |
| K853536 | Cp Medical | VELCRO FISTULA PRESSURE CLAMPS | 1985-10-17 | 55 |
| K831402 | Parker Hannifin Corp. | PRESSURE MONITOR & CONTROL UNIT APC-02A | 1983-08-08 | 98 |
Recalls for KXM devices
openFDA lists no recalls for product code KXM.
Frequently asked questions
What is FDA product code KXM?
KXM is the FDA product code for system accessories, extracorporeal. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is KXM?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code KXM?
Across 4 cleared submissions the average was 271 days from receipt to decision (median 76).
Which companies have the most KXM clearances?
Baxter Healthcare Corp (1); Colorado Medical, Inc. (1); Cp Medical (1); Parker Hannifin Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KXM
- Run a recall and safety report across every KXM manufacturer
- Watch product code KXM 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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