510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061515Substantially Equivalent

Renalsoft

Baxter Healthcare Corporation, Mcgaw Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061515 is the FDA 510(k) clearance record for RENALSOFT, a class II device, cleared for Baxter Healthcare Corp on under FDA product code KPF (System, Dialysate Delivery, Semi-Automatic, Peritoneal). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show 2 recalls naming K061515.

Clearance record

Decision date
Received
(102 days to decision)
Product code
KPF System, Dialysate Delivery, Semi-Automatic, Peritoneal
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Baxter Healthcare Corp 1620 Waukegan Rd., Mcgaw Park IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KPF

Trailing 12 months

FDA records hold no clearances under product code KPF in the trailing twelve months.

FDA records show no clearances under product code KPF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KPF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260