FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM
FDA 510(k) clearance K921456 · decided 1994-04-20
Clearance details
- K-number
- K921456
- Device name
- FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM
- Applicant
- Fresenius USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-03-27
- Decision date
- 1994-04-20
- Days to decision
- 754 days
- Clearance type
- Traditional
- Product code
- FKP
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Walnut Creek, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Fresenius USA
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 200 recall (Z-0629-2014) | Fresenius Medical Care Holdings, Inc. | 2014-01-06 |
| Fresenius 2008H Dialysate Delivery Machine, Manufactured by Fresenius USA Inc., Walnut Cre recall (Z-2224-2010) | Fresenius Medical Care North America | 2010-08-15 |
| Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis mach recall (Z-2227-2010) | Fresenius Medical Care North America | 2010-08-15 |