Who is the manufacturer of Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer?

Little Doctor Electronic (Nantong)Co.,Ltd filed the 510(k) submission for Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer (K193259).

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

K193259 · Little Doctor Electronic (Nantong)Co.,Ltd · DXQ · Jul 2, 2020 · Cardiovascular

Device Facts

Record ID	K193259
Device Name	Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
Applicant	Little Doctor Electronic (Nantong)Co.,Ltd
Product Code	DXQ · Cardiovascular
Decision Date	Jul 2, 2020
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. 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 non-invasive aneroid sphygmomanometer; includes inflation cuff, manual inflation bulb, and aneroid manometer gauge. Model NT-50 includes a stethoscope. Operated by medical professionals or patients at home. User wraps cuff around upper arm (or leg for children), manually inflates via bulb, and manually deflates via valve. User detects Korotkoff sounds (auscultatory method) to determine systolic and diastolic pressure. Output is visual reading on manometer scale (0-300 mmHg). Device aids in clinical blood pressure monitoring; provides manual, non-automated measurement.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing per ISO 10993-1, -5, -10 and performance testing per ISO 81060-1 confirmed compliance with specifications.

Technological Characteristics

Manual aneroid sphygmomanometer. Materials: aluminum/stainless steel manometer, PVC/latex tubing and inflation bulb, nylon/cotton cuff, PVC/latex bladder. Measurement range: 0-300 mmHg (2 mmHg intervals). Accuracy: ±3 mmHg. Biocompatibility per ISO 10993. Performance per ISO 81060-1. No software or electronic components.

Indications for Use

Indicated for measurement of systolic and diastolic blood pressure in newborns, infants, children, young adults, and adults. Used in hospital, home, office, and ambulance settings. Contraindications not specified.

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

RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-Automated Blood Pressure Meter with stethoscope, MODEL Max0201, Max0202, Max0203 (K190902)

Related Devices

K230859 — Aneroid Sphygmomanometer · Wenzhou Kangshun Medical Devices Co.,Ltd · Jun 28, 2023
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
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

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable. July 2, 2020 Little Doctor Electronic (Nantong) Co.,Ltd % Iris Du RA manager Little Doctor Electronic (Nantong)Co.,Ltd No.14, Zhenxingxilu Road, Chongchuan Area Nantong, 226000 CHINA Re: K193259 Trade/Device Name: Aneroid Sphygmomanometer Model NT-20, NT-201 Aneroid sphygmomanometer with stethoscope, Model NT-50 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ, LDE Dated: May 27, 2020 Received: June 1, 2020 Dear Iris Du: 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. 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 located 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}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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. For comprehensive regulatory information about medical devices and radiation-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. LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K193259 Device Name Aneroid Sphygmomanometer Model NT-20, NT-201 Aneroid Sphygmomanometer with Stethoscope, Model NT-50 Indications for Use (Describe) The device is intended to be used by medical professionals or in the measurement of systolic and diastolic pressure. 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." {3}------------------------------------------------ Sponsor:Little Doctor Electronic(Nantong)Co.,Ltd Subjective device: Aneroid sphygmomanometer Model NT-20, NT-201 Aneroid sphygmomanometer with stethoscope Model NT-50 # Chapter 6. 510(K) Summary # 1.submitter - Company name: Little Doctor Electronic(Nantong)Co.,Ltd - Address:No.14, Zhenxingxilu Road, Chongchuan Area, Nantong, Jiangsu, 226000, China - Postal Code:226000 - TEL:86-0513-80580127 - Contact person: Xinhua Pan (General Manager) Iris Du(RA Manager) - E-mail:dulh@lordmed.com ## 2.Subject Device Information - Model: NT-20, NT-201, NT-50 - Common name: Blood Pressure Kit(Blood Pressure Cuff) - Trade name: Aneroid sphygmomanometer Model NT-20, NT-201/ Aneroid sphygmomanometer with stethoscope, Model NT-50 - Product Code: DXQ,LDE - Regulation name: 21CFR 870.1120 (Blood pressure cuff)/21CFR 870.1875(Stethoscope) - Regulation class: II - Review Panel: Cardiovascular # 3.Predicate device - RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-Automated Blood Pressure Meter with stethoscope. MODEL Max0201,Max0202,Max0203,(K190902) {4}------------------------------------------------ Sponsor:Little Doctor Electronic(Nantonq)Co.,Ltd Subjective device: Aneroid sphygmomanometer Model NT-20, NT-201 Aneroid sphygmomanometer with stethoscope Model NT-50 #### 4.Intended use The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure. 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 Aneroid sphygmomanometer Model NT-20, NT-201/ Aneroid sphygmomanometer stethoscope, Model NT-50 are a manual non-invasive aneroid with sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories include cuff, inflation bulb, instruction manual and carrying case. Model NT-50 also includes a stethoscope. It is conjunction with stethoscope when use. This is subject device same as the predicate device(K190902) in terms of PVC or latex inflation bulb and the PVC or latex bladder. Besides, the material of added the optional various size of cuff (nylon or cotton cuff for this application)and the aluminum manometer are identical to the predicate device (K190902). #### 6. Substantial equivalence comparison It is substantially equivalence to the predicate device (K190902) RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-Automated Blood Pressure Meter with stethoscope MODEL Max0201,Max0202,Max0203 with respect to indication for use, device description, and technical description. All comparison table for applied device are as following, and the substantial equivalence determination is based on the 510(K) Substantial Equivalence Decision-Making Process Flowchart which includes the comparison and discussion of indication for use, technology, and performance specifications. {5}------------------------------------------------ # Sponsor:Little Doctor Electronic(Nantong)Co.,Ltd Subjective device: Aneroid sphygmomanometer Model NT-20, NT-201 Aneroid sphygmomanometer with stethoscope Model NT-50 The new device column includes the following device: Aneroid sphygmomanometer Model NT-20, NT-201/ Aneroid sphygmomanometer with stethoscope, Model NT-50 | Comparison item | Subject device: Aneroid sphygmomanometer Mode NT-20, NT-201/ Aneroid sphygmomanometer with stethoscope, Model NT-50 | Predicate device : RH non-Automated Blood pressure meter Model Max 02,RH non-Automated Blood pressure meter with stethoscope, Max0201,Max0202,Max02 03 | Result of comparison | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------| | Applicant | Little Doctor Electronic (Nantong)Co.,Ltd | Wenzhou Renhua Instruments Co.,Ltd | | | 510(K) number | Applying | K190902 | - | | Regulation number | 21 CFR 870.1120 | 21 CFR 870.1120 | Same | | Product code | DXQ.LDE | DXQ.LDE | Same | | Classificatio n | Class II | Class II | Same | | Intended use | The device is intended to be used by medical professional or at home for the measurement of systolic and diastolic pressure by detecting korotkoff sounds. | The device is intended to be used by medical professional or at home for the measurement of systolic and diastolic pressure by detecting korotkoff sounds. | Same | | Over-the-co unter use | Yes | Yes | Same | | Target | New born, Infants, children, | New born,Infants,children , | Same | | population | young adults,adults | young adults,adults | | | Where used | Hospital, home, office, and ambulance, etc. | Hospital, home, office, and ambulance, etc. | Same | | Anatomical sites | Upper arm(leg for child) | Upper arm(leg for child) | Same | | Measureme nt Method | Ausculatory Korotkoff sounds method | Ausculatory 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 | | The monitor scale | From 0 to 300mmHg with a minimum interval of 2 mmHg | From 0 to 300mmHg with a minimum interval of 2 mmHg | Same | | Design | The device comprised tubing attached to a cuff with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. | The device comprised tubing attached to a 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 | One type option: Single head | Three types option: Single head Dual head Rappaport | Similar | | Materials | The manometer :aluminum and stainless steel materials. The tubing ,inflation bulb:PVC or latex. Cuff:Nylon cloth or cotton cloth for outside layer. Cuff bladder:PVC or nature latex | The manometer :aluminum and stainless steel materials. The tubing ,inflation bulb:PVC or latex. Cuff:Nylon cloth or cotton cloth for outside layer. Cuff bladder:PVC or nature latex | Same | | Accuracy | Pressure : ±3mmHg of reading | Pressure : ±3mmHg of reading | Same | | Compatibility with environment | It can be used from 50°F to 104°F (10°C to 40°C) and 15%~85% RH humidity . | It can be used from 50°F to 104°F (10°C to 40°C) and 15%~85% RH humidity . | Same | | Cuff size | 185mm*55mm 255mm*75mm 345mm*110mm 500mm*140mm 540mm*145mm 615mm*175mm 780mm*220mm | 20"×5.5"(510mm*140mm) 21.7"×6.3"(550mm*160m m) 24.4"×6.9"(620mm*175m m) 28.3"×8.3"(720mm*210m m) 13.4"×4.15"(340mm*105m m) 10.2"×3"(260mm*75mm) | Similar | | Cuff circumference | Fits arm circumferences 100mm-660mm,the standard cuff should be available for use in measuring a child's leg blood pressure and for children with larger arms. | Fits arm circumferences 8.7"to 17.3" (220mm-440cm),the standard cuff should be available for use in measuring a child's leg blood pressure and for children with larger arms. | Similar | | Cuff bladder Size | 40mm*80mm 60mm*120mm 80mm*150mm 120mm*220mm 145mm*315mm 180mm*370mm | 8.7"×4.7"(220mm*120mm) 11.8"×5.9"(300mm*150m m) 13.4"×6.7"(340mm*170m m) 6.9"×3.3"(175mm*85mm) 7.5"×2"(190mm*50mm) | Similar | | Contents(with accessories) | Aneroid gauge,Arm cuff, inflation bulb, and instruction manual, stethoscope(option) | Aneroid gauge,Arm cuff, inflation bulb, and instruction manual, stethoscope(option) | Same | | Biocompatibili ty | Biocompatible as requirement of ISO 10993-1 ISO 10993-5 ISO 10993-10 | Biocompatible as requirement of ISO 10993-1 ISO 10993-5 ISO 10993-10 | Same | | performance | Compatible as requirement of ISO 81060-1 | Compatible as requirement of ISO 81060-1 | Same | {6}------------------------------------------------ # Sponsor:Little Doctor Electronic(Nantong)Co.,Ltd Subjective device: Aneroid sphygmomanometer Model NT-20, NT-201 Aneroid sphygmomanometer with stethoscope Model NT-50 {7}------------------------------------------------ # Sponsor:Little Doctor Electronic(Nantong)Co.,Ltd Subjective device: Aneroid sphygmomanometer Model NT-20, NT-201 Aneroid sphygmomanometer with stethoscope Model NT-50 {8}------------------------------------------------ # Sponsor:Little Doctor Electronic(Nantong)Co.,Ltd Subjective device: Aneroid sphygmomanometer Model NT-20, NT-201 Aneroid sphygmomanometer with stethoscope Model NT-50 {9}------------------------------------------------ ### Sponsor:Little Doctor Electronic(Nantonq)Co.,Ltd Subjective device: Aneroid sphygmomanometer Model NT-20, NT-201 Aneroid sphygmomanometer with stethoscope Model NT-50 ### Discussion: ### Same in details: - Compared with the predicate device(K190902) RH non-Automated Blood pressure meter Model Max 02,RH non-Automated Blood pressure meter with stethoscope, Max02 01, Max0202, Max0203, the subject device Aneroid sphygmomanometer Model NT-20, NT-201/ Aneroid sphygmomanometer with stethoscope, Model NT-50 are same as the predicate device(K190902) in terms of material s of the inflation bulb, tubing, cuff and manometer. - Predicate device (K190902) and subject device NT-20, NT-201, NT-50 have same classification,indication for use, target population, measurement method, product physical design and operation, performance parameter ranges,mechanical safety, anatomical sites, operation principles and etc. The structure of the predicate device (K190902) are same as the subject device ,which all have manometer, bulb, tube, various size of cuff and stethoscope(optional).The predicate device and subject device all have single head stethoscope. ### Difference in details: - The different sizes of the cuffs and bladders,cuff circumstance are provided in order to accommodate target population. All performance have been tested in this submission and do not raised any safety or effectiveness issue.All performance specification was verified to comply with the ISO 81060-1 standard. {10}------------------------------------------------ Sponsor:Little Doctor Electronic(Nantong)Co.,Ltd Subjective device: Aneroid sphygmomanometer Model NT-20, NT-201 Aneroid sphygmomanometer with stethoscope Model NT-50 ### 7. Non-clinical testing Non-clinical testing included biocompatibility and bench testing. The tests listed in the ISO 10993 and ISO 81060-1, were included. Results of testing were acceptable. ## 8. Clinical testing No clinical study is included in this submission. ## Conclusion RH non-automated blood pressure meter Model Max 02, non-automated blood pressure meter with stethoscope Model Max0201, Max 0202,Max0203(K190902) and subject device have the same intended use and similar technological characteristics. Moreover, information contained in this submission supplied demonstrates that any difference in their characteristic do not raise any new questions of safety or effectiveness. Thus, aneroid sphymomanometer Model NT-20, NT-201/ aneroid sphymomanometer with stethoscope, Model NT-50 are equivalent to the predicate device(K190902).