FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory
K Number: K201809
·
Decision Mar 10, 2021
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
343
Applicant Total
3
Review Days
252
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory
- K Number
- K201809
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baxter Healthcare Corportation
- Date Received
- July 1, 2020
- Decision Date
- March 10, 2021
- Product Code
- KDI
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KDI), ordered by most recent decision date.
NxStage System One with NxView
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ELISIO-H
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
multiFlux 130 (F00013123); multiFlux 160 (F00013124)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Tablo Hemodialysis System (PN-0008000, PN-0006000U)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FX CorAL 40; FX CorAL 50
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Purema H Hemoconcentrator - Pediatric
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology