Atlas FDA

HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310

FDA 510(k) clearance K053512 · decided 2006-02-16

Clearance details

K-number
K053512
Device name
HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
2005-12-16
Decision date
2006-02-16
Days to decision
62 days
Clearance type
Traditional
Product code
FKX
Device class
2
Regulation number
876.5630
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Mcgaw Park, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
APD Disposable Sets and Extension Sets used with Baxter HomeChoice and HomeChoice PRO Auto recall (Z-2129-2011)Baxter Healthcare Renal Div2011-05-03
Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers: 5C4471, 5C4471R, recall (Z-0799-2010)Baxter Healthcare Renal Div2010-03-01
HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R, R5 recall (Z-0800-2010)Baxter Healthcare Renal Div2010-03-01

PMA approvals by this applicant

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Floseal Hemostatic Matrix (P990009/S075)Baxter Healthcare Corp2025-01-30
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Floseal Hemostatic Matrix, RT5 (P990009/S070)Baxter Healthcare Corp2023-02-02