Cleared Traditional

K213507 - AquaA

K213507 is an FDA 510(k) clearance for AquaA, manufactured by Fresenius Medical Care Rental Therapies Group, LLC. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K213507 · Fresenius Medical Care Rental Therapies Group, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K213507

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.

FIP Device Classification - Class 2, Special Controls

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 27
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K213507.
AQUAbase nX
K223479 · B.Braun Medical, Inc. · Aug 2023
RenaPure Endotoxin Retentive Filter
K231410 · Evoqua Water Technologies, LLC · Jul 2023
AmeriWater MediQA Reverse Osmosis System (MSP3HF)
K223656 · AmeriWater, LLC · Feb 2023
U9000 Plus Ultrafilter
K211035 · Baxter Healthcare Corporation · Oct 2021
EON Portable RO Water Purification System
K200670 · Mar Cor Purification, Inc. · Apr 2020
Millenium HX
K192398 · Mar Cor Purification, Inc. · Oct 2019