← Product Code [CBP](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP) · K970780 # ONE-WAY VALVE (WITH CONNECTOR) (K970780) _Instrumentation Industries, Inc. · CBP · Sep 18, 1997 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K970780 ## Device Facts - **Applicant:** Instrumentation Industries, Inc. - **Product Code:** [CBP](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP.md) - **Decision Date:** Sep 18, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5870 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology ## Indications for Use The reusable BE 130 series One-Way Valves are designed for use in a breathing circuit or ventilatory system where “back flow” must be avoided. They are designed to prevent the flow of gas back toward the source. ## Device Story BE 130 Series One-Way Valves are mechanical components integrated into breathing circuits or ventilatory systems. Device functions as a uni-directional valve to prevent gas backflow toward the source. Used in clinical settings by healthcare professionals managing respiratory support. Device ensures unidirectional gas flow, protecting the source from potential contamination or pressure issues. No electronic, software, or algorithmic components. ## Clinical Evidence Bench testing only. ## Technological Characteristics Mechanical uni-directional valve; reusable; designed for integration into breathing circuits or ventilatory systems. ## Regulatory Identification A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere. ## 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 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Lori Zuravleff Instrumentation Industries, Inc. 2990 Industrial Boulevard Bethel Park, Pennsylvania 15102 SEP 18 1997 Re: K970780 BE 130 Series One-Way Valves Regulatory Class: II (two) Product Code: 73 CBP Dated: June 16, 1997 Received: June 23, 1997 Dear Ms. Zuravleff: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {1} Page 2 - Ms. Lori Zuravleff This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, ![img-0.jpeg](img-0.jpeg) Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} BE 130 Series # INDICATION FOR USE STATEMENT Device: BE 130 Series Reusable One-Way Valves Summary: Uni-directional valve to prevent back flow of gas in unintended, reverse direction toward source The reusable BE 130 series One-Way Valves are designed for use in a breathing circuit or ventilatory system where “back flow” must be avoided. They are designed to prevent the flow of gas back toward the source. ![img-1.jpeg](img-1.jpeg) Lori Zuravleff Typed Name February 28, 1997 Date K970780 Premarket notification (510(k)) number ![img-2.jpeg](img-2.jpeg) Page 4-1 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K970780](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBP/K970780) **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