510(k) K220721
- Device
- FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC
- 510(k) number
- K220721
- Product code
- KDI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-05-11
- Date received
- 2022-03-14
- 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
Applicant Contact#
- Contact
- Denise Oppermann
- Address
- 920 Winter St. Waltham MA US 02451 02451
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#
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 |
| K233557 | HemoCare Hemodialysis System | Deka Research and Development | 2024-07-12 |