Atlas FDA

AK 98 Dialysis Machine (955607)

FDA 510(k) clearance K250508 · decided 2025-08-01

Clearance details

K-number
K250508
Device name
AK 98 Dialysis Machine (955607)
Applicant
Vantive US Healthcare, LLC
Decision
Substantially Equivalent
Date received
2025-02-21
Decision date
2025-08-01
Days to decision
161 days
Clearance type
Traditional
Product code
KDI
Device class
2
Regulation number
876.5860
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Deerfield Lake, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Careflux H60;Careflux H70;Careflux V500 (K261267)Fresenius Medical Care Renal Therapies Group, LLC2026-07-24
NxStage System One with NxView (K252377)Fresenius Medical Care Renal Therapies Group, LLC2026-05-15
ELISIO™-H (K260533)Nipro Medical Corporation2026-03-19
multiFlux 130 (F00013123); multiFlux 160 (F00013124) (K252459)Fresenius Medical Care Renal Therapies Group, LLC2026-02-10
Tablo Hemodialysis System (PN-0008000, PN-0006000U) (K253412)Outset Medical, Inc.2026-01-26
FX CorAL 40; FX CorAL 50 (K253518)Fresenius Medical Care Renal Therapies Group, LLC2025-12-18
Purema H Hemoconcentrator - Pediatric (K243920)Medica USA, Inc.2025-09-19
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) (K243237)Fresenius Medical Care Renal Therapies Group, LLC2025-06-13
5008X Hemodialysis System (K243505)Fresenius Medical Care Renal Therapies Group, LLC2025-05-30
DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) (K242155)NIKKISO CO., LTD.2025-05-15
DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) (K243264)Sorin Group Italia S.R.L.2025-04-25
FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) (K242053)Fresenius Medical Care Renal Therapies Group, LLC2025-03-21

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Gambro Prismaflex TPE 2000 Set (P830063/S031)Vantive US Healthcare, LLC2025-12-23
Gambro Prismaflex TPE 2000 Set (P830063/S029)Vantive US Healthcare, LLC2024-12-06
Gambro Prismaflex TPE 2000 Set (P830063/S028)Vantive US Healthcare, LLC2024-10-24
Prismaflex TPE2000 Set (P830063/S027)Vantive US Healthcare, LLC2024-01-10
Gambro Prismaflex TPE 2000 Set (P830063/S026)Vantive US Healthcare, LLC2023-10-27
Prismaflex TPE2000 (P830063/S025)Vantive US Healthcare, LLC2023-03-29
Gambro Prismaflex TPE 2000 Set (P830063/S024)Vantive US Healthcare, LLC2022-11-08
Gambro Prismaflex TPE 2000 Set (P830063/S023)Vantive US Healthcare, LLC2022-04-07