ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE
FDA 510(k) clearance K874020 · decided 1988-01-29
Clearance details
- K-number
- K874020
- Device name
- ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1987-10-02
- Decision date
- 1988-01-29
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- KPF
- Device class
- 2
- Regulation number
- 876.5630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
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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 |
| PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (K955762) | Fresenius USA, Inc. | 1996-07-31 |
| TOTAL CONTAINMENT DEVICE (K913515) | Denco | 1994-05-26 |
| AMICON EQUALINE FLUID BALANCE SYSTEM (K875121) | Amicon, Inc. | 1988-02-19 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |