← Product Code [BTM](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM) · K970959 # INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT) (K970959) _Instrumentation Industries, Inc. · BTM · Jun 13, 1997 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K970959 ## Device Facts - **Applicant:** Instrumentation Industries, Inc. - **Product Code:** [BTM](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM.md) - **Decision Date:** Jun 13, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5915 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic, Pediatric ## Indications for Use On/Off control of oxygen flow when using a resuscitator bag. For use with hyperinflation bag (not included) weighing ~3 ounces - 4 pounds (90 - 1814 grams). The use of these sizes of bags typically range from neonatal, pediatric to adult care. The valves are intended to be used with a flowmeter (not included) which controls the flow of oxygen to the valve. On/off oxygen action is controlled by lifting/replacing bag on arm of valve. Immediate oxygen flow is provided when bag is lifted from arm (preventing personnel from having to turn oxygen on). Oxygen flow is stopped when bag is replaced. ## Device Story BE 3000 Series Instant Flow Valves provide mechanical on/off control for oxygen delivery systems. Device connects to external flowmeter and resuscitator/hyperinflation bag. Operation: lifting bag from valve arm triggers immediate oxygen flow; replacing bag on arm stops flow. Eliminates manual flowmeter adjustment by clinician during resuscitation. Used in clinical settings by healthcare personnel. Benefits include rapid oxygen delivery initiation and simplified workflow during patient ventilation. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Mechanical flow control valve. Dimensions/materials not specified. Standalone device; no software or electronic components. Manual operation via bag-actuated lever mechanism. ## Regulatory Identification A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. ## 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 JUN 13 1997 Ms. Lori Zuravleff Instrumentation Industries, Inc. 2990 Industrial Boulevard Bethel Park, Pennsylvania 15102 959 Re: K970599 * Instant Flow Valves Regulatory Class: II (two) Product Code: 73 BTM Dated: March 14, 1997 Received: March 17, 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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) 594-4646. 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 3000 Series # INDICATION FOR USE STATEMENT Device: BE 3000 Series Instant Flow Valves Summary: On/Off control of oxygen flow when using a resuscitator bag. For use with hyperinflation bag (not included) weighing ~3 ounces - 4 pounds (90 - 1814 grams). The use of these sizes of bags typically range from neonatal, pediatric to adult care. The valves are intended to be used with a flowmeter (not included) which controls the flow of oxygen to the valve. On/off oxygen action is controlled by lifting/replacing bag on arm of valve. Immediate oxygen flow is provided when bag is lifted from arm (preventing personnel from having to turn oxygen on). Oxygen flow is stopped when bag is replaced. ![img-1.jpeg](img-1.jpeg) Lori Zuravleff Typed Name March 14, 1997 Date K970959 Premarket notification (510(k)) number prescription 430 ✓ over-the-counter use ![img-2.jpeg](img-2.jpeg) Page 4-1 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K970959](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K970959) **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