QF10

K261470 · E.A.M Benelux B.V · NHV · Sep 9, 2026 · Gastroenterology, Urology

Device Facts

• Record ID: K261470
• Device Name: QF10
• Applicant: E.A.M Benelux B.V
• Product Code: NHV · Gastroenterology, Urology
• Decision Date: Sep 9, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Indications for Use

The QF10 is intended to be used to filter EPA quality drinking water. By retaining bacteria, the filter may aid in infection control. The filters produce water that is suitable for washing and drinking, superficial wound cleansing (minor cuts, scrapes, or abrasions), cleaning of equipment used in medical procedures and washing of surgeon's hands. The filter is not intended to provide water that can be used as a substitute for USP grade sterile water.

Device Story

Point-of-use water microfiltration device; attaches to handheld showerheads or plumbing fixtures; utilizes hollow-fiber membrane (0.08 μm nominal pore size) for physical size-exclusion of bacteria; incorporates silver-based bacteriostatic additive in housing to inhibit surface microbial growth; non-sterile; disposable; single-installation; 150-day or 7,000-liter service life; operated by clinicians or patients; provides filtered water for handwashing, equipment cleaning, and wound cleansing; aids in infection control; does not disinfect water; output used by healthcare providers to reduce microbial exposure during medical procedures.

Clinical Evidence

Bench testing only. Microbial retention validated per ASTM F838 (≥10⁷ CFU/cm² challenge; ≥10 log reduction). Silver-based additive efficacy tested per ISO 22196 (98.83%–99.94% reduction). Biocompatibility (cytotoxicity) confirmed; other endpoints addressed via risk-based justification. Structural integrity, flow rate, and shelf-life (5 years) verified under worst-case conditions.

Technological Characteristics

Hollow-fiber microfiltration; 0.08 μm nominal pore size; Polysulfone (PSU) membrane; ABS housing with silver-based bacteriostatic additive (ISO 22196); 3,400 cm² surface area; 1/2-inch NPSM threaded connection; non-sterile; 75 psi max pressure; 4°C-60°C operating temperature; physical size-exclusion mechanism.

Indications for Use

Indicated for use by patients and clinicians requiring filtered water for washing, drinking, superficial wound cleansing, and cleaning medical equipment. Not for use as a substitute for USP-grade sterile water.

Regulatory Classification

Identification

A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.

Special Controls

*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• FILT'RAY 2G Disposable Water Filters (K191563)

Reference Devices

• Nephros DSU-H/SSU-H Point-of-Use Water Filters (K141731)

Submission Summary (Full Text)

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September 9, 2026

E.A.M Benelux B.V
% Chezi Gerin
Principal Consultant
Merona Regulatory Partners
P.O. Box 3037
Biriya, 1380500
Israel

Re: K261470

Trade/Device Name: QF10

Regulation Number: 21 CFR 876.5665

Regulation Name: Water Purification System For Hemodialysis

Regulatory Class: Class II

Product Code: NHV

Dated: August 6, 2026

Received: August 6, 2026

Dear Chezi Gerin:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K261470 - Chezi Gerin

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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K261470 - Chezi Gerin

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Sincerely,

MAURA ROONEY -S

Maura Rooney

Assistant Director

DHT3A: Division of Renal, Gastrointestinal, Obesity, and Transplant Devices

OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices

Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261470 | ? |
| Please provide the device trade name(s). | | ? |
| QF10 | | |
| Please provide your Indications for Use below. | | ? |
| The QF10 is intended to be used to filter EPA quality drinking water. By retaining bacteria, the filter may aid in infection control. The filters produce water that is suitable for washing and drinking, superficial wound cleansing (minor cuts, scrapes, or abrasions), cleaning of equipment used in medical procedures and washing of surgeon's hands. The filter is not intended to provide water that can be used as a substitute for USP grade sterile water. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☐ Adults (22 years old and greater) | ? |

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K261470

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E.A.M Benelux B.V

# 510(k) Summary

# I. SUBMITTER

Company Name: EAM BENELUX B.V.

Contact Person: Ilan Aberman; [e-mail]

Date Prepared: 06-Aug-2026

# II. DEVICE

Trade Name: QF10

Common Name: System, Water purification, General medical use

Regulation Number: 21 CFR 876.5665

Regulation Name: Water purification system for hemodialysis

Regulatory Class: II

Product Code: NHV

Panel: Gastroenterology/Urology

Prescription Status: Rx Only

# III. PREDICATE DEVICE & REFERENCE DEVICE

Primary Predicate Device: FILT'RAY 2G Disposable Water Filters (K191563)

21 CFR 876.5665, Class II, NHV

Reference Device: Nephros DSU-H/SSU-H Point-of-Use Water Filters (K141731)

21 CFR 876.5665, Class II, NHV

# IV. DEVICE DESCRIPTION

The QF10 is a non-sterile, disposable, single-installation, point-of-use water microfiltration device intended for use with a handheld showerhead assembly or installation at the outlet of standard plumbing fixtures. The device is intended to provide filtered water for general medical uses, including washing surgeons' hands, cleaning equipment used in medical procedures, and superficial wound cleansing. Filtration is achieved through a hollow-fiber membrane with a nominal pore size of approximately 0.08 μm, which retains bacteria, including opportunistic waterborne microorganisms, by physical size-exclusion. Selected polymeric housing components incorporate a silver-based bacteriostatic additive intended to inhibit microbial growth on treated surfaces; the additive does not filter or disinfect the water. The QF10 does not contain natural rubber latex, tissues or by-products of animal origin, blood-derived materials, or medicinal substances. Each filter is intended for a single installation and must be replaced after 150 days or 7,000 liters, whichever occurs first.

# V. INDICATIONS FOR USE

The QF10 is intended to be used to filter EPA-quality drinking water. By retaining bacteria, the filter may aid in infection control. The filters produce water that is suitable for washing and drinking, superficial wound cleansing (minor cuts, scrapes, or abrasions), cleaning of equipment used in medical procedures and washing of surgeon's hands. The filter is not intended to provide water that can be used as a substitute for USP-grade sterile water.

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## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject and predicate devices have the same intended use and use the same fundamental hollow-fiber microfiltration mechanism to retain bacteria from EPA-quality drinking water. Both devices are intended for point-of-use applications, including shower and in-line configurations. The QF10 is supplied non-sterile, whereas the FILT'RAY 2G predicate is supplied sterile. These differences do not raise different questions of safety or effectiveness and were evaluated through microbial-retention, long-term durability, structural-integrity, pressure and temperature, flow, material-safety, silver-release, and biocompatibility testing. Comparable performance information for the sterile predicate and a legally marketed non-sterile reference device was evaluated to address the difference in sterility status.

| | Subject Device QF10 K261470 | Predicate Device FILT'RAY 2G K191563 | Reference Device DSU-H/SSU-H K141731 |
| --- | --- | --- | --- |
| Manufacturer Name | EAM BENELUX B.V. | Aqua-Tools | Nephros Inc. |
| Indications for use | Intended to be used to filter EPA quality drinking water. By retaining bacteria, the filter may aid in infection control. The filters produce water that is suitable for washing and drinking, superficial wound cleansing (minor cuts, scrapes, or abrasions), cleaning of equipment used in medical procedures and washing of surgeon's hands. The filter is not intended to provide water that can be used as a substitute for USP grade sterile water. | Intended to be used to filter EPA quality drinking water. By retaining bacteria, the filters may aid in infection control. The filters produce water that is suitable for washing and drinking, superficial wound cleansing (minor cuts, scrapes, or abrasions), cleaning of equipment used in medical procedures and washing of surgeon's hands. The filters are not intended to provide water that can be used as a substitute for USP grade sterile water. | Intended to be used to filter EPA quality drinking water. The filters retain bacteria, viruses, and endotoxin. By providing ultrapure water for patient washing and drinking, the filters aid in infection control. The filters produce water suitable for wound cleansing, cleaning equipment used in medical procedures, and washing of surgeon's hands. The filters are not intended to provide water that can be used as a substitute for USP sterile water. |
| Sterility | Non-sterile | Sterile; gamma irradiated | Non-sterile |
| Principle of operation | Hollow fiber microfiltration through physical size-exclusion | Hollow fiber microfiltration through physical size-exclusion | Hollow fiber ultrafiltration through physical size-exclusion |
| Membrane pore size | 0.08 μm nominal | 0.1 μm nominal / 0.2 μm absolute | 0.005 μm nominal |
| Membrane material | Polysulfone (PSU) | Polyethylene | Polysulfone (PSU) |
| Filtration surface area | 3,400 cm2 / 527 in2 | 3,200 cm2 | 28,000 cm2 |
| Housing material | ABS with silver ion additive | MBS with silver ion additive | ABS |
| Antimicrobial additive | silver ion additive; ISO 22196; ≥98.83%- | Silver ion additive; ISO 22196; >99.9%; | No antimicrobial additive identified |

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| | Subject Device QF10 K261470 | Predicate Device FILT'RAY 2G K191563 | Reference Device DSU-H/SSU-H K141731 |
| --- | --- | --- | --- |
| | ≥99.94%; <1.0 μg/L silver by ICP/MS | <1.0 μg/L silver by ICP/MS | |
| Retro-contamination / backflow feature | Non-return / backflow inhibition | Retro-contamination control features | No check-valve/backflow-prevention claim identified |
| Use life | 150 days or 7,000 L | Up to 4 months | Up to 6 months |
| Maximum inlet pressure | 75 psi / 5 bar | 72.5 psi / 5 bar | 100 psi / 6.8 bar |
| Operating temperature | 4°C-60°C normal operation; limited thermal exposure up to 70°C | 5°C-60°C; 70°C thermal shock | Max incoming temp: 60°C |
| Flow rate | 12 L/min at 5 bar | 9-11.9 L/min at 3 bar | 11.4 L/min at 4 bar |
| Microbial retention standard | ASTM F838 | ASTM F838 | ASTM F838 |
| ASTM F838 challenge basis | ≥10⁷ CFU/cm² | ≥10⁷ CFU/cm² | ≥10⁷ CFU/cm² |
| Bacterial retention/Microbial reduction | ≥10 log | ≥7 log | ≥11 log |
| Connections | Standard ½-inch NPSM threaded | Standard shower-hose fitting / adapters | Standard ½-inch NPSM threaded |

### VII. PERFORMANCE DATA

Non-clinical performance testing was conducted to characterize the subject QF10 and is summarized as follows:

#### Microbial Retention

The ability of the subject device to retain a bacterial load of ≥10⁷ colony-forming units (CFU)/cm² was captured via performance bench testing per ASTM F838: Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration. Testing was performed on devices subjected to defined worst-case use conditions. No B. diminuta was detected in the filtrates, and all tested devices met the predefined acceptance criteria.

#### Silver Ion Testing

The addition of a silver-based bacteriostatic agent into selected polymeric housing and showerhead materials was evaluated per ISO 22196. Treated polymer specimens demonstrated bacterial reductions ranging from 98.83% to at least 99.94%, depending on the tested material and microorganism. The presence of silver-based ions in water filtered through the QF10 was quantified via inductively coupled plasma mass spectrometry and found to be below the limit of quantification of 1.0 μg/L.

#### Maximum Operating Temperature and Pressure Rating

Testing verified device integrity and bacterial-retention performance at pressures up to 5 bar and temperatures up to 70°C under the specified worst-case exposure conditions. The QF10 maintained structural integrity and effective bacterial retention under these conditions.

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### Flow Rate Testing

The QF10 was subjected to flow rate and pressure testing under representative point-of-use conditions. Testing confirmed that the device provides adequate flow for the intended point-of-use application across the evaluated pressure range.

### Biocompatibility

Given the intended use, nature and degree of tissue contact, and exposure duration during use, the subject device is considered a surface device with limited duration exposure, based on a worst-case cumulative exposure duration of less than 24 hours. Exposure to device materials occurs primarily indirectly through the filtered water stream, with transient intact-skin contact during handling. The device materials do not directly contact breached or compromised surfaces, mucous membranes, blood, or internal tissues. Cytotoxicity testing was performed on the final finished device and demonstrated that the device is non-cytotoxic. Sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity were addressed through risk-based justification, material characterization, exposure assessment, and comparison to the predicate device. The biological evaluation supports the safety of the device for its intended use.

### Shelf Life Testing

Shelf-life performance for the QF10 was established through real-time aging studies conducted for a period of up to 5 years on the packaged device. Packaging integrity and functional performance were evaluated following real-time aging, as well as after transportation simulation, in order to confirm that the device maintains its intended performance characteristics throughout the labeled shelf life. All evaluated samples met the predefined acceptance criteria. The results demonstrate that the QF10 maintains packaging integrity and functional performance for the duration of the claimed shelf life of 5 years under the intended storage conditions.

### VIII. CONCLUSIONS

Comparison of the indications for use, technical characteristics, as well as performance of the subject and predicate water filters provided in the 510(k) submission, is sufficient to demonstrate substantial equivalence. The information contained in this 510(k) demonstrates that the QF10 is as safe and effective as the predicate.