Cleared Traditional

K213507 - AquaA (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213507 · Fresenius Medical Care Rental Therapies Group, LLC · Gastroenterology & Urology device
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Jul 2022
Decision
268d
Days
Class 2
Risk

K213507 is an FDA 510(k) clearance for the AquaA. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Fresenius Medical Care Rental Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on July 27, 2022 after a review of 268 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5665 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fresenius Medical Care Rental Therapies Group, LLC devices

Submission Details

510(k) Number K213507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2021
Decision Date July 27, 2022
Days to Decision 268 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 130d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FIP Subsystem, Water Purification
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5665
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FIP Subsystem, Water Purification

All 116
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K213507.
AquaC UNO H
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AquaA
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AquaBplus
K232953 · Fresenius Medical Care Renal Therapies Group, LLC · Jun 2024
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K223479 · B.Braun Medical, Inc. · Aug 2023