Atlas FDA

HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R

FDA 510(k) clearance K102936 · decided 2011-03-30

Clearance details

K-number
K102936
Device name
HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
2010-10-04
Decision date
2011-03-30
Days to decision
177 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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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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Recalls involving this device

RecordFirmDate
APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment o recall (Z-1056-2017)Baxter Healthcare Corporation2017-01-19
Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal recall (Z-0291-2016)Baxter Healthcare Corp.2015-11-17
The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro Automate recall (Z-1292-2015)Baxter Healthcare Corp.2015-03-18
AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and ad recall (Z-1245-2015)Baxter Healthcare Corp.2015-03-04
Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product recall (Z-1039-2015)Baxter Healthcare Corp.2015-02-02
HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Pr recall (Z-1031-2015)Baxter Healthcare Corp.2015-01-29
HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's HomeChoice recall (Z-0939-2015)Baxter Healthcare Corp.2015-01-07

PMA approvals by this applicant

RecordFirmDate
Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077)Baxter Healthcare Corp2025-11-13
FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076)Baxter Healthcare Corp2025-06-30
Floseal Hemostatic Matrix (P990009/S075)Baxter Healthcare Corp2025-01-30
Adept Adhesion Reduction Solution (P050011/S009)Baxter Healthcare Corp2024-08-23
Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074)Baxter Healthcare Corp2024-08-15
Floseal Hemostatic Matrix (P990009/S073)Baxter Healthcare Corp2024-01-10
Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072)Baxter Healthcare Corp2023-12-12
Floseal Hemostatic Matrix, RT5 (P990009/S070)Baxter Healthcare Corp2023-02-02