AquaA— 510(k) K213507

Name: FDA 510(k) clearance K213507
Creator: U.S. Food and Drug Administration
Published: 2022-07-27

Substantially Equivalent

Fresenius Medical Care Rental Therapies Group, LLC

FDA 510(k) clearance K213507 for AquaA, Substantially Equivalent on 2022-07-27. Applicant: Fresenius Medical Care Rental Therapies Group, LLC. Device class: 2.

Clearance details

Applicant: Fresenius Medical Care Rental Therapies Group, LLC
Product code: Code FIP
Device class: Class 2
Regulation: 21 CFR 876.5665
Advisory panel: Gastroenterology, Urology
Date received: 2021-11-01
Decision date: 2022-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FIP

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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

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.