System Accessories, Extracorporeal
The Extracorporeal System Accessories device encompasses accessories used with extracorporeal support systems, such as those employed in dialysis or hemofiltration, to maintain or supplement organ function outside the body. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KXM, regulated under 21 CFR 876.5820, in the Gastroenterology, Urology medical specialty. This device is designated as life-sustaining or life-supporting.
Research product code KXM in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- KXM
- Device Class
- FDA class 2
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K925581 | BAXTER BIOSTAT 1000 UREA MONITOR | May 03, 1995 | Substantially Equivalent | Baxter Healthcare Corp |
| K863471 | COLORADO MEDICAL MODEL PTC 1000 | Oct 02, 1986 | Substantially Equivalent | Colorado Medical, Inc. |
| K853536 | VELCRO FISTULA PRESSURE CLAMPS | Oct 17, 1985 | Substantially Equivalent | Cp Medical |
| K831402 | PRESSURE MONITOR & CONTROL UNIT APC-02A | Aug 08, 1983 | Substantially Equivalent | Parker Hannifin Corp. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.