← Product Code [BZD](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD) · K040726 # VENTLAB NASAL CPAP CANNULA (K040726) _Ventlab Corp. · BZD · Jun 3, 2004 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K040726 ## Device Facts - **Applicant:** Ventlab Corp. - **Product Code:** [BZD](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD.md) - **Decision Date:** Jun 3, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5905 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic ## Indications for Use The Ventlab Nasal CPAP Cannula is an accessory to positive pressure ventilation devices for patients suffering from Obstructive Sleep Apnea requiring CPAP therapy (i.e., CPAP, BiLevel). Federal (USA) law restricts this device to sale by or on the order of a physician. ## Device Story Ventlab Nasal CPAP Cannula functions as a patient interface accessory for positive pressure ventilation devices (CPAP/BiLevel). It delivers pressurized air to patients with Obstructive Sleep Apnea. Used in clinical or home settings under physician prescription. Device facilitates airway pressure delivery to assist patient breathing; benefits include management of sleep apnea symptoms. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Nasal cannula interface for positive pressure ventilation. Device is a non-continuous ventilator accessory (Product Code: BZD). ## Regulatory Identification A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing. ## 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/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "HUMAN SERVICES - USA" are written in a circular fashion above the symbol. The word "DEPARTMENT" is written in a circular fashion below the symbol. ## JUN 0 3 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Robert M. Kelly Director Regulatory Affairs Quality Assurance Ventlab Corporation 2934 Highway 601 North Mocksville, North Carolina 27028 Re: K040726 Trade/Device Name: Ventlab Nasal CPAP Cannula Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: March 18, 2004 Received: March 25, 2004 Dear Mr. Kelly: We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becares were is substantially equivalent (for the reletenced above and nave actemmed are to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate conmiseree pror to thay been reclassified in accordance with the provisions of Amendinents, on to devrees mat narvic Act (Act) that do not require approval of a premarket the rederal Pood, Drug, that Cosments , therefore, market the device, subject to the general approval appreation (1 MIT). " The general controls provisions of the Act include controls provisions of the First - Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (FMA), it may of subject to sach additions, Title 21, Parts 800 to 898. In the Close of your device can be found in the Could of Postering your device in the Federal Register. {1}------------------------------------------------ Page 2 - Mr. Kelly Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualice of a subscriptions with other requirements mean that FDA has made a determination that your device with other Federal agencies mean that FDA has made a decemmanon that your and regulations and more of the Act of the Act or registrative of the Act or any rederal statutes and regirations, including, but not limited to: registration You must comply with all the Act stars and a cold meanufacturing practice You must comply with an the Act 3 requirements increat 801); good manufacturing practice and listing (21 CFR Part 807); labeling (21 CFR Part 801); and i and listing (21 CFR Part 807), labelling (21 CFR Part 803), 3561 Part 820); and if requirements as set forth in the quality systems (QS) regulars (Sections 531-542 of the Act); applicable, the electronic product radiation control provisions (Sections 531-54 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) The Children and Charles of Charles of volusions of your device to a I his letter will anow you to begin manced.ing your device of your device to a premarket notification. The PDA Inding of otobalized of rour device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your device of the same . Also, please note the regulation please contact the Office of Comphance are (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act its tall f may obtail other general miormation on your resp. Division of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Binasa 2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use: unknown 510k Number : Applicant: Ventlab Corporation Device Name: Ventlab Nasal CPAP Cannula The Ventlab Nasal CPAP Cannula is an accessory to positive pressure The Ventiab Nasal CPAP Califical is an aboooory to people Sleep Apnea requiring ventilation devices for patients suffering from Obstructive Sleep Apnea requiring Posts for p ventifation device to: paint therapy (i.e., CPAP, BiLevel). Federal (USA) law restricts this device to sale by or on the order of a physician. ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED ## Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Cuy Sylvorn (Division Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Denta 510(k) Number --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K040726](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K040726) **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