Optiflux dialyzer
FDA 510(k) clearance K162488 · decided 2017-04-06
Clearance details
- K-number
- K162488
- Device name
- Optiflux dialyzer
- Applicant
- Fresenius Medical Care North America
- Decision
- Substantially Equivalent
- Date received
- 2016-09-07
- Decision date
- 2017-04-06
- Days to decision
- 211 days
- Clearance type
- Traditional
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Optiflux High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5S recall (Z-0041-2026) | Fresenius Medical Care Holdings, Inc. | 2025-10-03 |
| Dialyzer Optiflux 160NRe recall (Z-0801-2025) | Fresenius Medical Care Holdings, Inc. | 2025-01-03 |