Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

53 results for "Fresenius Medical Care Renal Therapies Group, LLC"
1–24 of 53
Search insights Median review: 148d Cleared: 100% Top manufacturer: Fresenius Medical Care Renal Therapies Group, LLC Lead specialty: Gastroenterology & Urology
Cleared CT Oct 19, 2026
multiFiltratePRO System
K261203 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 189d
Cleared Jul 24, 2026
Careflux H60
K261267 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 99d
Cleared May 15, 2026
NxStage System One with NxView
K252377 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 289d
Cleared Feb 10, 2026
multiFlux 130 (F00013123)
K252459 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 189d
Cleared Jan 29, 2026
NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)
K253462 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 114d
Cleared Dec 18, 2025
FX CorAL 40
K253518 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 36d
Cleared Nov 24, 2025
BCM2-Body Composition Monitor
K250634 · DSB
Fresenius Medical Care Renal...
Gastroenterology & Urology · 266d
Cleared Nov 14, 2025
AquaC UNO H
K250471 · FIP
Fresenius Medical Care Renal...
Gastroenterology & Urology · 269d
Cleared Oct 09, 2025
DIASAFEplusUS (F00013010)
K251851 · FIP
Fresenius Medical Care Renal...
Gastroenterology & Urology · 115d
Cleared Sep 09, 2025
Bicarby Dialysate RFP-404 (RFP-404-W)
K252180 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 60d
Cleared Jun 13, 2025
2008T HD SYS. CDX BLUESTAR (191124)
K243237 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 246d
Cleared May 30, 2025
5008X Hemodialysis System
K243505 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 199d
Cleared Apr 04, 2025
Bicarby Dialysate RFP-402 (RFP-402-G)
K243786 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 116d
Cleared Apr 03, 2025
stay•safe® catheter extension set with Safe- Lock, 12 inch
K250404 · KDJ
Fresenius Medical Care Renal...
Gastroenterology & Urology · 50d
Cleared Mar 21, 2025
FX CorAL 40 (F00009214)
K242053 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 252d
Cleared Feb 28, 2025
FX CorAL 60 (F00012969)
K243874 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 73d
Cleared Jun 13, 2024
AquaBplus
K232953 · FIP
Fresenius Medical Care Renal...
Gastroenterology & Urology · 266d
Cleared May 31, 2024
multiFlux 1000 (F00012408)
K240394 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 113d
Cleared May 10, 2024
pureFLOW 402 (F00012067)
K233950 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 148d
Cleared Apr 15, 2024
Novalung ultimate kit (US)
K232926 · QJZ
Fresenius Medical Care Renal...
Cardiovascular · 208d
Cleared Dec 06, 2023
2008T BlueStar Hemodialysis Machine
K231125 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 230d
Cleared Dec 01, 2023
pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502,...
K233159 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 65d
Cleared May 31, 2023
CombiSet Hemodialysis Blood Tubing Set
K213992 · FJK
Fresenius Medical Care Renal...
Gastroenterology & Urology · 526d
Cleared May 11, 2023
FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL...
K220721 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 423d