DIACLEAR ULTRAFILTER— 510(k) K003957

Name: FDA 510(k) clearance K003957
Creator: U.S. Food and Drug Administration
Published: 2001-11-01

Substantially Equivalent

Gambro Renal Products

FDA 510(k) clearance K003957 for DIACLEAR ULTRAFILTER, Substantially Equivalent on 2001-11-01. Applicant: Gambro Renal Products. Device class: 2.

Clearance details

Applicant: Gambro Renal Products
Product code: Code FIP
Device class: Class 2
Regulation: 21 CFR 876.5665
Advisory panel: Gastroenterology, Urology
Date received: 2000-12-21
Decision date: 2001-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FIP

view all

K250471 — AquaC UNO H2025-11-14
K251851 — DIASAFEplusUS (F00013010)2025-10-09
K252181 — AquaA2025-09-09
K250514 — UPT Series Medical RO Water Treatment System2025-03-17
K232953 — AquaBplus; AquaB LITE2024-06-13

More clearances from Gambro Renal Products

view all

K120333 — PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY2012-05-25
K072908 — PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY2008-02-04
K070414 — GAMBRO CARTRIDGE BLOOD SETS2007-10-12
K063290 — GAMBRO QUICKSET BLOODLINES2007-01-30
K062090 — PRISMA SYSTEM R03.10A2006-10-18

Adverse events under product code FIP

product code FIP

Malfunction: 490
Total: 490

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.