← Product Code [CBK](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK) · K030515 # HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS (K030515) _Hans Rudolph, Inc. · CBK · May 2, 2003 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K030515 ## Device Facts - **Applicant:** Hans Rudolph, Inc. - **Product Code:** [CBK](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK.md) - **Decision Date:** May 2, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5895 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic ## Indications for Use The Hans Rudolph 7500 Series Reusable Oro-Nasal NIV Masks are intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. The mask is multi-patient reusable. It is intended for use on adult patients above 30 kilograms weight, who are appropriate candidates for noninvasive ventilation, in the home, hospital, or other clinical setting. ## Device Story Hans Rudolph 7500 Series Reusable Oro-Nasal NIV Masks serve as patient interface for noninvasive ventilation (NIV). Device connects to ventilators equipped with alarms/safety systems for respiratory failure/insufficiency treatment. Multi-patient reusable design. Used in home, hospital, or clinical settings by clinicians or patients. Provides seal for positive pressure delivery; facilitates gas exchange; supports respiratory function. No electronic or software components. ## Clinical Evidence Bench testing only. ## Technological Characteristics Reusable oro-nasal mask interface for noninvasive ventilation. Designed for adult patients >30kg. Mechanical interface; no electronic components, sensors, or software. Multi-patient reusable materials. ## Regulatory Identification A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device. ## 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} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service MAY - 2 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Kevin Rudolph Vice President Hans Rudolph, Incorporated 7200 Wyandotte Kansas City, Missouri 64114 Re: K030515 Trade/Device Name: Hans Rudolph 7500 Series Reusable Oro-Nasal NIV Masks Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: 73 CBK Dated: January 13, 2003 Received: February 19, 2003 Dear Mr. Rudolph: 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. 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 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} Page 2 – Mr. Rudolph 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} Page 1 of 1 # INDICATIONS FOR USE STATEMENT 510(k) Number: K030515 Device Name: Hans Rudolph 7500 Series Reusable Oro-Nasal NIV Masks Indications For Use: The Hans Rudolph 7500 Series Reusable Oro-Nasal NIV Masks are intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. The mask is multi-patient reusable. It is intended for use on adult patients above 30 kilograms weight, who are appropriate candidates for noninvasive ventilation, in the home, hospital, or other clinical setting. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) [Signature: S. W. W. K. S.] (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: K030515 Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use ☐ (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K030515](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K030515) **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