← Product Code [JCX](/submissions/SU/subpart-e%E2%80%94surgical-devices/JCX) · K011725 # OLYMPUS SUCTION PUMP, MODEL KV-5 (K011725) _Keymed (Medical & Industrial Equipment), Ltd. · JCX · Aug 31, 2001 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JCX/K011725 ## Device Facts - **Applicant:** Keymed (Medical & Industrial Equipment), Ltd. - **Product Code:** [JCX](/submissions/SU/subpart-e%E2%80%94surgical-devices/JCX.md) - **Decision Date:** Aug 31, 2001 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4780 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended Use For aspiration during flexible endoscopy and general or surgical suction within a health care establishment. It is not intended for thoracic, domiciliary, field or transport use. ## Device Story Olympus Suction Pump Model KV-5 is a medical suction device designed for aspiration during flexible endoscopy and general surgical procedures. Operated by healthcare professionals within clinical environments, the device provides vacuum suction to remove fluids or debris. It is not intended for thoracic surgery or use in home, field, or transport settings. The device functions as a standard suction pump to assist in maintaining clear surgical or endoscopic fields, thereby facilitating procedural visibility and patient safety. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Electrically powered suction pump for medical aspiration. Designed for use in healthcare establishments. Form factor is a standalone unit. No software or complex algorithms described. ## Regulatory Identification A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter. ## 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 AUG 3 1 2001 Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle or other bird-like figure with three wing-like shapes extending from its body. The image is in black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Roger Gray Head of Quality Assurance and Regulatory Affairs KeyMed (Medical & Industrial Equipment) Ltd. KeyMed House Stock Road, Southend-on-Sea Essex SS2 5OH United Kingdom Re: K011725 Trade/Device Name: Olympus Suction Pump Model KV-5 Regulation Number: 878.4780 Regulatory Class: II Product Code: JCX Dated: May 21, 2001 Received: June 4, 2001 Dear Mr. Gray: 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 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). 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 - Mr. Roger Gray 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) 594-4659. 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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, Lisa Wlmefr Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Appendix 5 ## INDICATIONS FOR USE STATEMENT 510(k) Number (if known): צוגרונס או א Unknown Olympus Suction Pump model KV-5 Device Name: Indications For Use: For aspiration during flexible endoscopy and general or surgical suction within a health care establishment. It is not intended for thoracic, domiciliary, field or transport use. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… Concurrence of CDRH, Office of Device Evaluation (ODE) SR (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number k011725 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JCX/K011725](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JCX/K011725) **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. 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