510(k) K233557

Device: HemoCare Hemodialysis System
Applicant: Deka Research and Development
510(k) number: K233557
Product code: KDI
Decision: Substantially Equivalent (SESE)
Decision date: 2024-07-12
Date received: 2023-11-06
Regulation: 876.5860
Classification name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Medical specialty: Gastroenterology, Urology
Review panel: Gastroenterology, Urology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Related Records

Applicant Contact

Contact: Paul Smolenski
Address: 340 Commercial St. Manchester NH US 03101 03101

FDA Registration Numbers

3000247873
3002807408
3005162618
3003464075
8041145
3001744144
9611369
3015472042
3015349756
3003337893
1047843
3032828299
9680579
1225714
3002879653
8030639
3013188547
3014479313
9610825
3013764800
3008307705
3038195011
3010355846
3004176176
3008229990
3011554160
3004111573
3013536188
1000312731
9610987
3027592507
9616074
1649518
3003661577
3015335038
3004530184
3010377171
3005578748
1000286794
3003589956
9680841
3043226252
3007137787
3010383847
3010291427
8010182
9615942
3016678045
3014272786
3017552925
3003504604
3006174295
3031565407
9616240
3033903155
1713747
9681834
3043014136
3008102042
3016096143
3021632375
8030665
3005941719
3012494290
2032098
2183744
9611823
3012149633
3005695808
9681465
3040314808
3035708507
3038138522
3020689844
3004201412
1721676
3014579161
3016250252
3013557562
8010026

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code KDI

510(k)	Device	Applicant	Decision date
K252377	NxStage System One with NxView	Fresenius Medical Care Renal Therapies Group, LLC	2026-05-15
K260533	ELISIO-H	Nipro Medical Corporation	2026-03-19
K252459	multiFlux 130 (F00013123); multiFlux 160 (F00013124)	Fresenius Medical Care Renal Therapies Group, LLC	2026-02-10
K253412	Tablo Hemodialysis System (PN-0008000, PN-0006000U)	Outset Medical, Inc.	2026-01-26
K253518	FX CorAL 40; FX CorAL 50	Fresenius Medical Care Renal Therapies Group, LLC	2025-12-18
K243920	Purema H Hemoconcentrator - Pediatric	Medica USA, Inc.	2025-09-19
K250508	AK 98 Dialysis Machine (955607)	Vantive US Healthcare, LLC	2025-08-01
K243237	2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)	Fresenius Medical Care Renal Therapies Group, LLC	2025-06-13
K243505	5008X Hemodialysis System	Fresenius Medical Care Renal Therapies Group, LLC	2025-05-30
K242155	DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)	NIKKISO CO., LTD.	2025-05-15
K243264	DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)	Sorin Group Italia S.R.L.	2025-04-25
K242053	FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)	Fresenius Medical Care Renal Therapies Group, LLC	2025-03-21
K243874	FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975)	Fresenius Medical Care Renal Therapies Group, LLC	2025-02-28
K233798	Moda-flx Hemodialysis System and Cartridge	Diality, Inc.	2024-08-02
K240394	multiFlux 1000 (F00012408)	Fresenius Medical Care Renal Therapies Group, LLC	2024-05-31