Cleared Traditional

K261470 - QF10

K261470 is an FDA 510(k) clearance for QF10, manufactured by E.A.M Benelux B.V. The device is a Class 2 Gastroenterology & Urology device with product code NHV cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K261470 · E.A.M Benelux B.V · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Sep 2026
Decision
128d
Days
Class 2
Risk

K261470 is an FDA 510(k) clearance for the QF10. Classified as System, Water Purification, General Medical Use (product code NHV), Class II - Special Controls.

Submitted by E.A.M Benelux B.V (Almere, NL). The FDA issued a Cleared decision on September 9, 2026 after a review of 128 days - within the typical 510(k) review window.

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 E.A.M Benelux B.V devices

FDA 510(k) Submission Details - K261470

510(k) Number K261470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2026
Decision Date September 09, 2026
Days to Decision 128 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
3d faster than avg
Panel avg: 131d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHV Device Classification - Class 2, Special Controls

Product Code NHV System, Water Purification, General Medical Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5665
Definition The Device Is A Portable Water Treatment System Which Features Components And Technology Similar To Water Treatment Systems Previously Cleared For Hemodialysis. The Difference Lies With The Intended Use, As The Proposed Device Is Not Intended For Use In Hemodialysis Applications, For Which A Product Code Currently Exists. Instead, The Proposed Device Is Intended For Use To Purify Water For General Purposes, Including Washing Of Surgeons Hands, Surgical Instruments, And Wound Cleansing.
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 Consultant

Merona Regulatory Partners
Chezi Gerin

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NHV System, Water Purification, General Medical Use

All 11
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