PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
FDA 510(k) clearance K955762 · decided 1996-07-31
Clearance details
- K-number
- K955762
- Device name
- PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
- Applicant
- Fresenius USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-12-18
- Decision date
- 1996-07-31
- Days to decision
- 226 days
- Clearance type
- Traditional
- Product code
- KPF
- Device class
- 2
- Regulation number
- 876.5630
- 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.
| Record | Firm | Date |
|---|---|---|
| RENALSOFT (K061515) | Baxter Healthcare Corp | 2006-09-11 |
| RENAL LINK (K990953) | Baxter Healthcare Corp | 1999-06-18 |
| CYBERREN (K970989) | Cybernius Medical , Ltd. | 1997-07-24 |
| TOTAL CONTAINMENT DEVICE (K913515) | Denco | 1994-05-26 |
| AMICON EQUALINE FLUID BALANCE SYSTEM (K875121) | Amicon, Inc. | 1988-02-19 |
| ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE (K874020) | Abbott Laboratories | 1988-01-29 |
| C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP (K821328) | Medionics International , Ltd. | 1982-07-28 |
| GAMBRO PERITONEAL DIALYSIS MONITOR (K802831) | Gambro, Inc. | 1980-12-18 |
| CYCLER W/5 OR 10 HR. FILL/DWELL TIMER (K800496) | American Medical Products, Inc. | 1980-07-21 |
| PERITONEAL DIALYSIS CYCLER MODEL PDC1000 (K791676) | J.M. Sounds Electronics Co. | 1979-12-06 |
| CYLER/HEATER FOR PERITONEAL DIALYSIS (K791584) | American Medical Products, Inc. | 1979-11-16 |
| AMP AUTOMATIC CYCLER STAND (K790091) | American Medical Products, Inc. | 1979-02-16 |
Recalls involving this device
No recalls on record reference this clearance.