Biomoneta Avata Rx

K251872 · Biomoneta Research Private Limited · FRF · Nov 14, 2025 · General Hospital

Device Facts

• Record ID: K251872
• Device Name: Biomoneta Avata Rx
• Applicant: Biomoneta Research Private Limited
• Product Code: FRF · General Hospital
• Decision Date: Nov 14, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5045
• Device Class: Class 2

Indications for Use

The Biomoneta Avata Rx is an over-the-counter (OTC) medical recirculating air cleaner intended to remove particles for medical purposes. The device is intended for indoor use only. The Biomoneta Avata Rx has been demonstrated to reduce Staphylococcus epidermidis, Klebsiella aerogenes, and MS2 bacteriophage by > 5 log when operated at its highest fan speed for 60 minutes. Note: The designation “Rx” in the product name is part of the trade name and does not indicate prescription status.

Device Story

Biomoneta Avata Rx is an OTC medical recirculating air cleaner for indoor use. Device functions by drawing in ambient air and processing it to remove particles; specifically demonstrated to reduce Staphylococcus epidermidis, Klebsiella aerogenes, and MS2 bacteriophage by > 5 log at highest fan speed over 60 minutes. Operated by users in indoor settings to improve air quality for medical purposes. Output is purified air; benefits patient by reducing bioaerosol and particle concentrations in the environment.

Clinical Evidence

Bench testing only. Performance validated in controlled test chambers measuring 9.1 ft x 9.1 ft x 7 ft for bioaerosol and 12 ft x 12.5 ft x 15 ft for particle reduction. Demonstrated > 5 log reduction of Staphylococcus epidermidis, Klebsiella aerogenes, and MS2 bacteriophage after 60 minutes of operation at highest fan speed.

Technological Characteristics

Medical recirculating air cleaner; utilizes fan-based air circulation for particle removal. Indoor use only. No specific materials, connectivity, or software algorithm details provided.

Indications for Use

Indicated for use as an OTC medical recirculating air cleaner for indoor environments to remove particles for medical purposes.

Regulatory Classification

Identification

A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

November 14, 2025

Biomoneta Research Private Limited
% Amrutha Rai
I3CGlobal Reghelps PVT LTD.
MR-02, D-4, First Floor, ClayWorks Shankaraa, H&G
Shankaraa, Kanakapura Rd, Doddakallasandra
Bengaluru, Karnataka 560062
India

Re: K251872
Trade/Device Name: Biomoneta Avata Rx
Regulation Number: 21 CFR 880.5045
Regulation Name: Medical Recirculating Air Cleaner
Regulatory Class: Class II
Product Code: FRF
Dated: October 15, 2025
Received: October 15, 2025

Dear Amrutha Rai:

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.

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

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K251872 - Amrutha Rai
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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" (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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 systems (QS) regulation (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-

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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).

Sincerely,

KATHARINE SEGARS -S

Katharine Segars, Ph.D.
Assistant Director
DHT4C: Division of Infection Control Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K251872

Device Name
Biomoneta Avata Rx

Indications for Use (Describe)
The Biomoneta Avata Rx is an over-the-counter (OTC) medical recirculating air cleaner intended to remove particles for medical purposes. The device is intended for indoor use only.
The Biomoneta Avata Rx has been demonstrated to reduce Staphylococcus epidermidis, Klebsiella aerogenes, and MS2 bacteriophage by > 5 log when operated at its highest fan speed for 60 minutes.

Note: The designation “Rx” in the product name is part of the trade name and does not indicate prescription status.

Performance was validated in controlled test chambers measuring 9.1 ft × 9.1 ft × 7 ft (bioaerosol) and 12 ft × 12.5 ft × 15 ft (particle reduction).

Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C)

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