Who is the manufacturer of Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer?

Wenzhou Longwan Medical Device Factory filed the 510(k) submission for Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer (K240165).

What is the FDA product code for Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer?

DXQ. It is classified under 21 CFR 870.1120 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer

K240165 · Wenzhou Longwan Medical Device Factory · DXQ · Mar 20, 2024 · Cardiovascular

Device Facts

Record ID	K240165
Device Name	Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer
Applicant	Wenzhou Longwan Medical Device Factory
Product Code	DXQ · Cardiovascular
Decision Date	Mar 20, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1120
Device Class	Class 2
Attributes	Pediatric

Intended Use

The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on new borns, infants, children, young adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.

Device Story

Manual blood pressure monitor; consists of inflatable cuff, inflation bulb, pressure gauge, air valve, and optional stethoscope. Operator wraps cuff around patient's upper arm or leg; manually inflates using bulb; listens for Korotkoff sounds via stethoscope while manually controlling deflation via valve. Pressure gauge displays systolic and diastolic readings in mmHg. Used in hospitals, clinics, ambulances, or home settings by medical professionals or patients. Provides visual pressure data to assist healthcare providers in clinical decision-making regarding patient cardiovascular status.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ISO 81060-1:2007 for non-automated sphygmomanometers and biocompatibility testing per ISO 10993-5:2009, ISO 10993-10:2021, and ISO 10993-23:2021.

Technological Characteristics

Manual aneroid sphygmomanometer. Materials: Nylon cloth (cuff), Neoprene/Silicon/Latex/PVC (tubing/bulb/bladder), Aluminum/ABS (gauge). Measurement range: 0-300 mmHg; interval: 2 mmHg. Accuracy: ± 3 mmHg. Auscultatory measurement principle. No software or electronic components.

Indications for Use

Indicated for measurement of systolic and diastolic blood pressure in newborns, infants, children, and young adults. Intended for use by medical professionals or in home settings.

Regulatory Classification

Identification

A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

Predicate Devices

Aneroid sphygmomanometer, Aneroid sphygmomanometer with stethoscope (K211084)

Related Devices

K230859 — Aneroid Sphygmomanometer · Wenzhou Kangshun Medical Devices Co.,Ltd · Jun 28, 2023
K173246 — ANEROID SPHYGMOMANOMETER · Wenzhou Bokang Instruments Co., Ltd. · May 30, 2018
K092245 — ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100 · Honsun (Nantong) Co., Ltd. · Oct 28, 2009
K212416 — WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203 · Wenzhou Xikang Medical Instruments Co., Ltd. · May 18, 2022
K221857 — Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201 · Zhejiang Lude Technology Development Co., Ltd. · Oct 13, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 20, 2024 Wenzhou Longwan Medical Device Factory Bernard Zeng, Manager Unit 4, Building 27, No. 706 Yanyun Road, Oujiangkou Industrial Cluster District Wenzhou. Zhejiang 325026 China Re: K240165 Trade/Device Name: Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXO, LDE Dated: January 15, 2024 Received: January 22, 2024 Dear Bernard Zeng: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. {2}------------------------------------------------ For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Stephen C. Browning -S LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K240165 Device Name ## ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE; ANEROID SPHYGMOMANOMETER #### Indications for Use (Describe) The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on new borns, infants, children, young adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ## 510(K) Summary Prepared in accordance with the requirements of 21 CFR Part 807.92 #### Prepared Date: Dec. 11,2023 ## 1. Submitter's Information The submitter of this pre-market notification is: | Name: | WENZHOU LONGWAN MEDICAL DEVICE FACTORY | |-----------------|----------------------------------------------------------------------------------------------------------------------| | Address: | Unit 4, Building 27, No. 706 Yanyun Road, Oujiangkou Industrial Cluster District, Wenzhou, Zhejiang, 325026 China | | Contact person: | Bernard Zeng | | Title: | Manager | | E-mail: | bernard@taiyumed.com | | Tel: | 86-13957715667 | ## 2. Device Identification | 510(K) number: | TBD | |--------------------|-------------------------------------------| | Trade/Device Name: | ANEROID SPHYGMOMANOMETER, | | | ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE | | Common name: | Blood Pressure Cuff | | Regulation Number: | 870.1120 | | Regulation Name: | Blood Pressure Cuff | | Regulation Class: | Class 2 | | Panel: | Cardiovascular | | Product Code: | DXQ,LDE | ## 3. Predicate Device | 510(K) number: | K211084 | |--------------------|-------------------------------------------| | Trade/Device Name: | Aneroid sphygmomanometer, | | | Aneroid sphygmomanometer with stethoscope | | Common name: | Blood Pressure Cuff | | Regulation Number: | 870.1120 | | Regulation Name: | Blood Pressure Cuff | | Regulation Class: | Class 2 | | Panel: | Cardiovascular | | Product Code: | DXQ,LDE | {5}------------------------------------------------ Traditional 510(k) Submission of ANEROID SPHYGMOMANOMETER #### 4. Indication for Use The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on new borns, infants, children, young adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. #### 5. Device Description The ANEROID SPHYGMOMANOMETER and ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE are manual blood pressure monitor used to measure blood presure.It consists of a cuff,a inflation bulb,a pressure gauge, an air valve and a stethoscope(optional). Cuff: The cuff is made of a durable fabric and is wrapped around the upper arm of the patient. It inflates and deflates during the measurement process. The material of outside layer is nylon cloth. Inflation Bulb: The inflation bulb is a rubber bulb that connects to the cuff and is used to manually inflate the cuff with air. The material is Neoprene or Silicon rubber or Nature latex or PVC. Pressure Gauge: The pressure gauge is a circular dial with a needle that indicates the pressure within the cuff. It is calibrated in millimeters of mercury (mmHg) and shows the systolic and diastolic blood pressure readings. The material is Aluminum or ABS. Air Valve: The valve is a control mechanism that allows for the release of air from the cuff once the measurement is complete. Stethoscope: Although not a part of the device itself, a stethoscope is typically used in conjunction with an Aneroid Sphygmomanometer to listen for the blood flow sounds, known as Korotkoff sounds, in the brachial artery during the measurement. Three model are single head Stethoscope(Model: TY-S01),Dual Head Stethoscope(Model: TY-S05) and Spraque Rappaport Stethoscope(Model: TY-S04) individually.These stethoscopes are listed in FDA database. #### 6. Compared to Predicate Device Compared to the predicate devices, the subject device has the same intended use, similar product design, similar performance, same safety as the predicate device, the summarized comparison information is listed in the following table | SE Comparisons | Subject Device | Predicate Device | Similarities/ Differences | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | 510(K) number | TBD | K211084 | / | | Name | ANEROID SPHYGMOMANOMETER, ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE | Aneroid sphygmomanometer, Aneroid sphygmomanometer with stethoscope | Same | | Indication for Use | The device is intended to be used by medical professionals | The device is intended to be used by medical professionals | Same | | | or in the home for the measurement of systolic and diastolic pressure on new borns, infants, children, young adults and adults. The device is intended to be manually attached to a patient and manually inflated along with a | or in the home for the measurement of systolic and diastolic pressure on new borns, infants, children, young adults and adults. The device is intended to be manually attached to a patient and manually inflated along with a | | | | manual method for detecting Korotkoff sounds. | manual method for detecting Korotkoff sounds. | | | Product code | DXQ,LDE | DXQ,LDE | Same | | Class | II | II | Same | | Regulation Number | 21 CFR 870.1120 | 21 CFR 870.1120 | Same | | Common name | Blood Pressure Cuff | Blood Pressure Cuff | Same | | Type of Use | Over the Counter | Over the Counter | Same | | Environment of Use | Home, Hospital, healthcare facility,ambulance etc. | Home, Hospital, healthcare facility, ambulance etc. | Same | | Target population | New borns, infants, children, young adults and adults | New borns, infants, children, young adults and adults | Same | | Site | Upper Arm (leg for child) | Upper Arm (leg for child) | Same | | Measurement Method | Auscultatory Korotkoff sounds Method | Auscultatory Korotkoff sounds Method | Same | | Inflation | Manual by inflation bulb | Manual by inflation bulb | Same | | Deflation | Manual deflation via valve | Manual deflation via valve | Same | | Display | Aneroid Manometer | Aneroid Manometer | Same | | Monitor scale | From 0 to 300 mmHg with a minimum interval of 2 mmHg. | From 0 to 300 mmHg with a minimum interval of 2 mmHg. | Same | | Design of the device | The device comprises tubing attached to a soft inelastic cuff with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. | The device comprises tubing attached to a soft inelastic cuff with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. | Same | | Design of Stethoscope | Three types option: Single head Dual head Sprague Rappaport | Three types option: Single head Dual head Sprague Rappaport | Same | | Materials | The manometer: aluminum or ABS The tubing, inflation bulb and cuff bladder: Neoprene or Silicon rubber or Nature latex or PVC Cuff: Nylon cloth for outside layer | The manometer: aluminum or ABS The tubing, inflation bulb and cuff bladder: Neoprene or Silicon rubber or Nature latex or PVC Cuff: Nylon cloth for outside layer | Same | | Accuracy | ± 3 mmHg | ± 3 mmHg | Same | | Cuff sizes | 500 ×140mm 350 ×100mm 600 ×170mm 780 × 220mm 260 × 80mm 200 × 60mm 255 × 75mm 380 × 110mm 560 × 150mm 660 × 170mm 760 × 210mm | 800mm × 220mm 620mm × 175mm 520mm × 140mm 340mm × 110mm 250mm × 80mm 210mm × 60mm | Different, See Note 1 | | Cuff circumference | Fits arm circumferences 60mm-660mm, the standard cuff should be available for use in measuring a New born, infant, child's leg blood pressure and for child, young adult, and adult with larger arms | Fits arm circumferences 100mm-620mm, the standard cuff should be available for use in measuring a New born, infant, child's leg blood pressure and for child, younq adult, and adult with larger arms | Different, See Note 1 | | Cuff bladder size | 220 × 120mm 175 × 85mm 315 × 145mm 375 × 185mm 110 × 60mm 80 × 40mm 115 × 55mm 175 × 80mm 215 × 120mm 310 × 140mm 340 × 170mm | 340mm × 170mm 310mm × 140mm 220mm × 120mm 170mm × 80mm 110mm × 60mm 80mm × 40mm | Different. See Note 1 | | Biocompatibility | ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021 | ISO 10993-5:2009, ISO 10993-10:2010 | Different, See Note 2 | | Performance | ISO 81060-1:2007 | ISO 81060-1:2007 | Same | {6}------------------------------------------------ #### Traditional 510(k) Submission of ANEROID SPHYGMOMANOMETER {7}------------------------------------------------ #### Traditional 510(k) Submission of ANEROID SPHYGMOMANOMETER Note 1: All of the cuff were tested alongside aneroid sphygmomanometer according to ISO 81060-1:2007, these differences do not affect safety and effectiveness. Note 2: The skin irritation testing and skin sensitization testing were conducted in accordance with ISO 10993-23:2021 and ISO 10993-10:2021 due to the version update of the standard, this difference does not affect safety and effectiveness. The subject device and predicate device are substantially equivalent in the areas of technological characteristics such as basic design, features, method of operation, general function, {8}------------------------------------------------ Traditional 510(k) Submission of ANEROID SPHYGMOMANOMETER application, and intended use. The subject device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices. ## 8. Performance Testing Summary #### The subject device comply with: #### Clinical test: Clinical testing is not required. #### Non-clinical data #### Safety and performance ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type #### Biocompatibility ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity ISO 10993-10:2021 Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization ISO 10993-23:2021 Biological Evaluation of Medical Devices - Part 23: Tests for Irritation #### 9. Conclusion The conclusions drawn from the nonclinical tests demonstrate that the subject devices ANEROID SPHYGMOMANOMETER,ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE are as safe, as effective, and performs as well as the legally marketed predicated devices Aneroid sphygmomanometer,Aneroid sphygmomanometer with stethoscope(K211084).