← Product Code [DXN](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN) · K093907 # WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE (K093907) _Welch Allyn, Inc. · DXN · Apr 14, 2010 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K093907 ## Device Facts - **Applicant:** Welch Allyn, Inc. - **Product Code:** [DXN](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN.md) - **Decision Date:** Apr 14, 2010 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 870.1130 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Pediatric, 3rd-Party Reviewed ## Intended Use The Welch Allyn Non-Invasive Blood Pressure device is intended to be used by clinicians and medically qualified personnel for the acquisition and attended monitoring of noninvasive blood pressure and pulse rate of neonatal through adult patients. The Welch Allyn Non-Invasive Blood Pressure device may be used for treatment and diagnostic spot NIBP measurements or attended NIBP monitoring in hospital general wards, clinics, and doctor's offices. ## Device Story Device consists of software running on laptop PC and NIBP module; uses standard blood pressure cuffs and tubing. Operates via oscillometric method to measure systolic/diastolic blood pressure and pulse rate; calculates Mean Arterial Pressure (MAP). Used by clinicians/medically qualified personnel in hospitals, clinics, and doctor's offices for spot checks or attended monitoring. Data displayed on laptop LCD; assists clinicians in diagnostic and treatment decisions. Benefits include non-invasive patient assessment. ## Clinical Evidence No clinical trials performed. Safety and performance validated via bench testing according to ANSI/AAMI SP10: 2002 (R2008) standard for manual, electronic, or automated sphygmomanometers, including amendments 1 and 2. ## Technological Characteristics Oscillometric BP measurement principle; powered via USB from laptop PC. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-4 (programmable electrical medical systems), and AAMI SP10 (sphygmomanometers). ## Regulatory Identification A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body. ## Predicate Devices - Welch Allyn Spot Ultra Vital Signs Device ([K040490](/device/K040490.md)) - VSM- Vital Signs Monitor (VSM 300) ([K063419](/device/K063419.md)) ## Reference Devices - Welch Allyn VSM 53000 ## Related Devices - [K170966](/device/K170966.md) — TONOPORT VI · Par Medizintechnik GmbH & Co. KG · Jun 14, 2017 - [K243115](/device/K243115.md) — Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) · Shenzhen Urion Technology Co., Ltd. · Feb 21, 2025 - [K141984](/device/K141984.md) — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR · Andon Health Co, Ltd. · Apr 29, 2015 - [K994423](/device/K994423.md) — AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 · Vsm Medtech , Ltd. · Mar 28, 2000 - [K082357](/device/K082357.md) — MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODELWATCHBP OFFICE (TWIN200). · Microlife Intellectual Property GmbH · Oct 29, 2008 ## Submission Summary (Full Text) {0}------------------------------------------------ K093907 Image /page/0/Picture/1 description: The image shows the word "Allyn" in bold, black font. Above the word "Allyn" is the number 1867. The font is a serif font. i Abbreviated 510(k) Premarket Notification Welch Allyn Non-invasive Blood Pressure (NIBP) Device ### Premarket Notification [510(k)] Summary 6. February 3, 2010 Date: APR 1 4 2010 Submitted By: Welch Allyn. Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 (315) 685-3694 Phone: Fax: (315) 685- 2532 Contact: Huy Doan, Senior Manager, Regulatory Affairs Common Name: Non-invasive Blood Pressure (NIBP) Device Trade Name: Welch Allyn Non-invasive Blood Pressure (NIBP) Device Classification Name: Noninvasive blood pressure measurement system Class II; Product Code: DXN- 21 CFR 870.1130 Modification to VSM- Vital Signs Monitor (VSM 300) (K063419) Predicate Devices: Welch Allyn Spot Ultra Vital Signs Device (K040490) The Welch Allyn NIBP device consists of 1) a software program running on a Description: laptop computer; 2) an NIBP module which measures and reports the patient's blood pressure and pulse rate readings. The device is intended to operate with a series of standard blood pressure cuffs and blood pressure tubing. The Welch Allyn NIBP device is designed to non-invasively measure systolic and diastolic blood pressure and pulse rate for adult, pediatric and neonatal patients using the oscillometric method. The Welch Allyn NIBP device will also calculate Mean Arterial Pressure (MAP). All blood pressure and pulse values are displayed on the large, easy-to-read LCD display of the laptop computer. The Welch Allyn NIBP device is intended for use in a wide variety of health care settings. This includes hospital departments; alternate care settings, such as physician offices, freestanding ambulatory care and surgery centers, health clinics and nursing homes. Indications for Use: The Welch Allyn Non-Invasive Blood Pressure device is intended to be used by clinicians and medically qualified personnel for the acquisition and attended monitoring of noninvasive blood pressure and pulse rate of neonatal through adult patients. The Welch Allyn Non-Invasive Blood Pressure device may be used for treatment and diagnostic spot NIBP measurements or attended NIBP monitoring in hospital general wards, clinics, and doctor's offices. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image contains the text "Welch Allyn" in a stylized font. The word "Welch" is in a lighter, less bold font compared to "Allyn." The text appears to be a logo or brand name. #### Premarket Notification [510(k)] Summary 6. # Contraindications for Use: The Welch Allyn Non-Invasive Blood Pressure device is not intended for use with severe arrhythmia. The Welch Allyn Non-Invasive Blood Pressure device is not intended for patients who are experiencing convulsions or tremors. # Technological Characteristics: The Welch Allyn NIBP Device utilizes an Oscillometric BP Algorithm that is equivalent to the BP Algorithm in the Spot Ultra Vital Signs and Welch Allyn VSM 53000. The Welch Allyn NIBP Device is powered from USB power from the Laptop PC. It uses the same operating principle and incorporates the same basic material. The subject device has the same technological characteristics as the predicate devices. # Non-clinical performance data: The subject device was also tested to evaluate its safety and effectiveness based on the following standards: - IEC 60601-1:1988+Al:1991+A2:1995 Medical electrical equipment Part 1: . General requirements for basic safety and essential performance - IEC 60601-1-2:2001+Al:2004 Medical Electrical Equipment Part 1-2: . General requirements for safety - collateral standard: Electromagnetic compatibility - Requirements and Test - IEC 60601-1-4:(2000) General Requirement for Safety: Collateral Standard: . Programmable Electrical Medical Systems - AAMI SP10: 2002: Manual, electronic or automated sphygmomanometers . (A1:2003, A2:2006) # Clinical performance data: Clinical safety and performance requirements were met based on the ANSI/AAMI SP10: 2002 (R2008) standard for Manual, electronic or automated sphygmomanometers + Amendment 1 & 2 standards # Conclusions: The intended use and the technological characteristics of the Welch Allyn NIBP device are the same as the predicate devices and the product meets FDA's recognized concensus standards. Therefore Welch Allyn believes the Welch Allyn NIBP device is substantially equivalent to the predicate devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling an emblem. The emblem is a stylized representation of a human figure embracing an eagle, symbolizing the department's mission to protect and promote the health and well-being of all Americans. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002 APR 1 4 2010 Welch Allyn, Inc. c/o Mr. Daniel W. Lehtonen Sr. Staff Engineer - Medical Devices Intertek Testing Services NA, Inc. 2307 East Aurora Road, Unit B7 Twinsburg, OH 44087 #### Re: K093907 Trade/Device Name: Welch Allyn Non-Invasive Blood Pressure (NIBP) Device Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: March 18, 2010 Received: March 22, 2010 Dear Mr. Lehtonen: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {3}------------------------------------------------ Page 2 -- Mr. Daniel W. Lehtonen 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, [signature] Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): ≤093907 Device Name: Welch Allyn Non-invasive Blood Pressure (NIBP) Device Indications for Use: The Welch Allyn Non-Invasive Blood Pressure device is intended to be used by clinicians and medically qualified personnel for the acquisition and attended monitoring of noninvasive blood pressure and pulse rate of neonatal through adult patients. The Welch Allyn Non-Invasive Blood Pressure device may be used for treatment and diagnostic spot NIBP measurements or attended NIBP monitoring in hospital general wards, clinics, and doctor's offices. Prescription Use × AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) W.W.C. (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K093590 Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K093907](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K093907) **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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