Atlas FDA

PrisMax System Version 3

FDA 510(k) clearance K193482 · decided 2020-03-13

Clearance details

K-number
K193482
Device name
PrisMax System Version 3
Applicant
Baxter Healthcare Corporation
Decision
Substantially Equivalent
Date received
2019-12-17
Decision date
2020-03-13
Days to decision
87 days
Clearance type
Traditional
Product code
KDI
Device class
2
Regulation number
876.5860
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Brooklyn Park, MN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Baxter Healthcare Corporation

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
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
AK 98 Dialysis Machine (955607) (K250508)Vantive US Healthcare, LLC2025-08-01
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

Recalls involving this device

RecordFirmDate
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724 recall (Z-2438-2025)VANTIVE US HEALTHCARE LLC2025-08-26
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 95 recall (Z-2439-2025)VANTIVE US HEALTHCARE LLC2025-08-26

PMA approvals by this applicant

RecordFirmDate
Preveleak Surgical Sealant (P100030/S021)Baxter Healthcare Corporation2025-07-10
PerClot® Polysaccharide Hemostatic System (P210036/S005)Baxter Healthcare Corporation2025-04-25
Preveleak Surgical Sealant 4mL; Preveleak Delivery Tips 10 PK (P100030/S020)Baxter Healthcare Corporation2025-04-11
PerClot Polysaccharide Hemostatic System (P210036/S002)Baxter Healthcare Corporation2024-12-20
Seprafilm Adhesion Barrier (P950034/S059)Baxter Healthcare Corporation2024-12-19
PerClot Polysaccharide Hemostatic System (P210036/S004)Baxter Healthcare Corporation2024-07-18
Seprafilm Adhesion Barrier (P950034/S058)Baxter Healthcare Corporation2024-07-03
Preveleak Surgical Sealant, Preveleak 10-Pack delivery Tips (P100030/S019)Baxter Healthcare Corporation2024-06-06