← Product Code [FRF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF) · K112728 # HEPAIRX VENTILATING AIR PURIFIER (K112728) _Air Innovations, Inc. · FRF · Jan 23, 2013 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K112728 ## Device Facts - **Applicant:** Air Innovations, Inc. - **Product Code:** [FRF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF.md) - **Decision Date:** Jan 23, 2013 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5045 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for Use Filtering out airborne particulates from air for medical purposes. HEPAirX 100 is intended for over-the-counter use. ## Device Story HEPAirX 100 is a medical recirculating air cleaner; functions by filtering airborne particulates from the environment for medical purposes. Designed for over-the-counter use; intended to improve air quality by removing particulate matter. Device operates as a standalone unit; provides continuous air filtration. Benefits patient by reducing exposure to airborne contaminants in medical or home environments. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Medical recirculating air cleaner; 21 CFR 880.5045; Product Code FRF. Standalone unit; utilizes mechanical filtration to remove airborne particulates. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and is oriented to follow the curve of the circle. The logo is black and white. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 23, 2013 Mr. Lawrence Wetzel Chairman Air Innovations, Incorporated 7000 Performance Drive NORTH SYRACUSE NY 13212 Re: K112728 Trade/Device Name: HEPAirX 100 Regulation Number: 21 CFR 880.5045 Regulation Name: Medical Recirculating Air Cleaner Regulatory Class: II Product Code: FRF Dated: January 9, 2013 Received: January 15, 2013 ## Dear Mr. Wetzel: 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 (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. 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. {1}------------------------------------------------ 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucml15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Anthony De min Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Section 4.0 of Original Application ## Indications for Use 510(k) Number (if known): KU2728 Device Name: HEPAirX 100 Indications for Use: Filtering out airborne particulates from air for medical purposes. HEPAirX 100 is intended for over-the-counter use. Prescription Use NO (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use YES (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Shula A. Murphy @ Arts TMCB. Chf 1/23/2013 Sign-On) of Anesthesiology, General Hospital on Control, Dental Devices 510(k) Number: 4 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K112728](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K112728) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com