Atlas FDA

BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST

FDA 510(k) clearance K935659 · decided 1994-07-07

Clearance details

K-number
K935659
Device name
BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
1993-11-24
Decision date
1994-07-07
Days to decision
225 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

+ Add to Predicate Builder ◉ Watch Baxter Healthcare Corp

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.

RecordFirmDate
Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5) (K250523)Simergent, LLC2025-10-02
Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 (K243371)Byonyks Pvt, Ltd.2025-05-16
Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App (K220935)Iren-Medical, Ltd.2022-12-29
Fresenius Liberty Select Cycler (K222318)Fresenius Medical Care Renal Therapies Group, LLC2022-10-31
Lilliput APD System (K212522)Fresenius Medical Care Renal Therapies Group, LLC2022-04-15
CloudCath Peritoneal Dialysis Drain Set Monitoring System (K212658)Cloudcath2022-02-09
Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System (K201867)Baxter Healthcare Corporation2020-11-19
Fresenius Liberty Select Cycler (K181108)Fresenius Medical Care Renal Therapies Group, LLC2018-05-24
Liberty Cycler Set (K173718)Fresenius Medical Care Renal Therapies Group, LLC2018-05-01
Fresenius Liberty Select Cycler (K171652)Fresenius Medical Care Renal Therapies Group, LLC2017-09-15
Amia Automated PD System with Sharesource (K151525)Deka Research and Development2015-10-09
LIBERTY PDX CYCLER (K141145)Fresenius Medical Care Renal Therapies Group, LLC2014-07-30

Recalls involving this device

No recalls on record reference this clearance.

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