Who is the manufacturer of Disposable Temperature Probe?

Shenzhen Launch Electrical Co., Ltd. filed the 510(k) submission for Disposable Temperature Probe (K181967).

What is the FDA product code for Disposable Temperature Probe?

FLL. It is classified under 21 CFR 880.2910 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Disposable Temperature Probe?

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

What are the predicate devices for Disposable Temperature Probe?

Temperature Probes (General purpose/ Skin) (K121999).

Who can help prepare an FDA 510(k) submission like Disposable Temperature Probe?

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.

Disposable Temperature Probe

K181967 · Shenzhen Launch Electrical Co., Ltd. · FLL · Dec 10, 2018 · General Hospital

Device Facts

Record ID	K181967
Device Name	Disposable Temperature Probe
Applicant	Shenzhen Launch Electrical Co., Ltd.
Product Code	FLL · General Hospital
Decision Date	Dec 10, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.2910
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Disposable Temperature Probe (body surface type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's skin temperature. The Disposable Temperature Probe (celomic type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's oral, rectal, nasopharyngeal cavity temperature.

Device Story

Disposable temperature probe; thermistor-based sensor; connects to compatible medical monitor (e.g., COMEN Model C30). Input: thermal energy from patient body; output: electrical resistance change converted to temperature reading by monitor. Used in clinical settings by professionals for continuous monitoring (up to 24 hours). Body surface type (axilla) uses adhesive foam; celomic type (oral, rectal, nasopharyngeal) inserted into cavities. Provides real-time temperature data to clinicians for patient assessment and clinical decision-making.

Clinical Evidence

Bench testing only. Device performance verified against IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and ISO 80601-2-56 (clinical thermometer performance). Biocompatibility confirmed via ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization).

Technological Characteristics

Thermistor-based sensing; non-sterile; single-use. Materials: Foam (sticker), PVC (probe). Dimensions: 750mm length. Connectivity: Wired connection to compatible medical monitor. Standards: IEC 60601-1, IEC 60601-1-2, ISO 80601-2-56, ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for continuous temperature monitoring in adult and pediatric patients. Body surface type for skin temperature; celomic type for oral, rectal, or nasopharyngeal cavity temperature. Prescription use only.

Regulatory Classification

Identification

A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

Special Controls

(1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.

Predicate Devices

Temperature Probes (General purpose/ Skin) (K121999)

Reference Devices

Esophageal/Rectal Temperature Probe (K140134)
SureTemp® Plus (K030580)

Related Devices

K193338 — Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes · Shenzhen Med-Link Electronics Tech Co., Ltd. · Aug 25, 2020
K070339 — DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES · Cincinnati Sub-Zero Products, Inc. · Sep 26, 2007
K182755 — Disposable Temperature Probe · Shenzhen Caremed Medical Technology Co., Ltd. · Dec 21, 2018
K121999 — GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE · Draeger Medical GmbH · Feb 28, 2013
K251160 — Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) · Shenzhen Med-Link Electronics Tech Co., Ltd. · Jan 8, 2026

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. December 10, 2018 Shenzhen Launch Electrical Co., LTD % Tracy Che Registered Engineer Feiying Drug & Medical Consulting Technical Service Group B-3F-3005, Bldg.1, Southward Ruifeng Business Center, No. 22 Guimiao Road Shenzhen, Guangdong, 518000 China Re: K181967 Trade/Device Name: Disposable Temperature Probe. Model: TAS03-14. TAS03-15. TAS03-16. TAS03-17 (body surface type); TAE03-09S, TAE03-10S, TAE03-11S, TAE03-12S, TAE03-13S, TAE03-14S, TAE03-15S, TAE03-16S (celomic type) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 8, 2018 Received: November 13, 2018 Dear Tracy Che: 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 {1}------------------------------------------------ Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Sapana Patel -S For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K181967 #### Device Name Disposable Temperature Probe/ Model: TAS03-14, TAS03-16, TAS03-17 (body surface type); TAE03-10S, TAE03-11S, TAE03-12S, TAE03-13S, TAE03-14S, TAE03-15S, TAE03-16S (celomic type) #### Indications for Use (Describe) The Disposable Temperature Probe (body surface type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's skin temperature. The Disposable Temperature Probe (celomic type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's oral, rectal, nasopharyngeal cavity temperature. Type of Use (Select one or both, as applicable) | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | |---------------------------------------------------------------------------------------------------------------------------------------------------| | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | #### 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}------------------------------------------------ # 510 (k) Summary This "510(k) Summary" is submitted in accordance with requirements of Title 21, CFR Section 807.92. # K181967 ## (1) Applicant information | 510 (k) owner's name: | SHENZHEN LAUNCH ELECTRICAL CO., LTD | |-----------------------|-------------------------------------| |-----------------------|-------------------------------------| | Address: | NO. F Building, Zhonggangxing Industrial Estate, Zhangge Community, Guanlan Street, Longhua New District, Shenzhen, China | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------| | Contact person: | Jiaan Huang | | Phone number: | +86-755-29532401 | | Fax number: | +86-755-29532483 | | Email: | yuanhe@cnlaunch.com | | Date of summary prepared: | 2018.12.07 | # (2) Proprietary name of the device | Trade name/Model: | Disposable Temperature Probe/ Model: TAS03-14, TAS03-15, TAS03-16, TAS03-17 (body surface type); TAE03-09S, TAE03-10S, TAE03-11S, TAE03-12S, TAE03-13S, TAE03-14S, TAE03-15S, TAE03-16S (celomic type) | |--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulation name: | Clinical electronic thermometer | | Regulation number: | 21 CFR 880.2910 | | Product code | FLL | | Review panel: | General hospital | | Regulation class: | Class II | # (3) Predicate and reference device - 彩 Predicate device | Sponsor | Dräger Medical GmbH | |-----------------------|--------------------------------------------| | Device Name and Model | Temperature Probes (General purpose/ Skin) | | 510(k) Number | K121999 | | Product Code | FLL | | Regulation Number | 21 CFR 880.2910 | | Regulation Class | II | {4}------------------------------------------------ | Sponsor | Starboard Medical, LLC | Welch Allyn, Incorporated | |-----------------------|----------------------------------------|---------------------------| | Device Name and Model | Esophageal/Rectal Temperature Probe | SureTemp® Plus | | 510(k) Number | K140134 | K030580 | | Product Code | BZT, FLL | FLL | | Regulation Number | 21 CFR 868.1920 21 CFR 880.2910 | 21 CFR 880. 2910 | | Regulation Class | II | II | - Reference device જુન ## (4) Description/ Design of device The Disposable Temperature Probe is a noninvasive, quick-acting, safe and secure way for continuous temperature monitoring. It provides an effective way for doctors to obtain patient's temperature. The Disposable Temperature Probe obtains temperature information through the influence degree that the thermal balance has on the resistance value of thermistor sensor after it has contacted human body. The Disposable Temperature Probe is intended to be connected to a compatible medical monitor which is Model C30 (Manufacturer: COMEN) to continuously measure the patient's temperature, which can only be used by professionals for single use. It has two types which are body surface type (model: TAS03-15. TAS03-16. TAS03-17) and celomic type (model: TAE03-09S, TAE03-10S, TAE03-12S, TAE03-13S, TAE03-13S, TAE03-14S, TAE03-15S, TAE03-16S). The body surface type is mainly pasted under the axilla while the celomic type is inserted into the oral, rectal or nasopharyngeal cavity. The temperature probes should not be used for more than 24 hours. The Disposable Temperature Probe is composed of plug, cable and temperature sensing probe. For patient-contacting components, their materials have all ## (5) Indications for use been tested and evaluated for biocompatibility. The Disposable Temperature Probe (body surface type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's skin temperature. The Disposable Temperature Probe (celomic type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's oral, rectal, nasopharyngeal cavity temperature. | Component of Device Requiring Biocompatibility | Material of Component | Body Contact Category (ISO 10993-1) | Contact Duration (ISO 10993-1) | |------------------------------------------------------|--------------------------|----------------------------------------|-----------------------------------| |------------------------------------------------------|--------------------------|----------------------------------------|-----------------------------------| #### (6) Materials {5}------------------------------------------------ | Sticker | Foam | Surface-contacting device: Intact skin | < 24hours | |---------|------|------------------------------------------------|-----------| | Probe | PVC | Surface-contacting device: Mucosal membrane | < 24hours | The body-contacting material used in Disposable Temperature Probe have all passed biocompatibility test. # (7) Technological characteristics and substantial equivalence | Item | Targeted device | Predicate device | Reference device | Reference device | Remark | |-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------| | Trade name | Disposable Temperature Probe/Model: TAS03-14, TAS03-15, TAS03-16, TAS03-17 (body surface type); TAE03-09S, TAE03-10S, TAE03-11S, TAE03-12S, TAE03-13S, TAE03-14S, TAE03-15S, TAE03-16S (celomic type) | Temperature Probes (General purpose/ Skin) | Esophageal/ Rectal Temperature Probe | SureTemp® Plus | / | | 510 (k) number | K181967 | K121999 | K140134 | K030580 | / | | Regulation number | 21 CFR 880.2910 | 21 CFR 880.2910 | 21 CFR 868.1920 21 CFR 880.2910 | 21 CFR 880. 2910 | Same | | Product code | FLL | FLL | BZT, FLL | FLL | Same | | Class | II | II | II | II | Same | | Indications for use/ Intended use | The Disposable Temperature Probe (body surface type) is to be used with a compatible | General Purpose Temperature Probes Dräger disposable | The Esophageal/ Rectal Temperature Probe is indicated for | The Welch Allyn SureTemp® Plus is intended to be used by healthcare professionals to | Similar Note 5 | | | medical | general purpose | continuous | provide an | | | | monitor that | temperature | monitoring of | accurate | | | | has temperature | probes are | esophageal, | prediction of | | | | measurement | intended for | rectal, and | patient | | | | function to | patient core | nasopharyngeal | temperature | | | | continuously | body | temperatures. | using the oral, | | | | measure the | temperature | | axillary or rectal | | | | patient's skin | measurement in | | body sites in 4 to | | | | temperature. | combination | | 15 seconds or to | | | | The Disposable | with Dräger and | | provide an | | | | Temperature | Siemens patient | | actual | | | | Probe (celomic | monitoring | | temperature | | | | type) is to be | systems. The | | reading in the | | | | used with a | probes are | | continuous | | | | compatible | inserted into the | | monitor mode in | | | | medical | oesophagus or | | about 3 minutes. | | | | monitor that | the rectum. | | | | | | has temperature | Skin | | | | | | measurement | Temperature | | | | | | function to | Probes | | | | | | continuously | Dräger | | | | | | measure the | disposable skin | | | | | | patient's oral, | temperature | | | | | | rectal, | probes are | | | | | | nasopharyngeal | intended for | | | | | | cavity | patient skin | | | | | | temperature. | temperature | | | | | | | measurement in combination | | | | | | | | | | | | | | with Dräger and | | | | | | | Siemens patient | | | | | | | monitoring | | | | | | | systems. The | | | | | | | probes are | | | | | | | affixed on the | | | | | | | patient's skin | | | | | | | with an adhesive | | | | | | | cover. | | | | | Suitable for the | Adult and | Adult, pediatric | / | / | Same | | crowd | pediatric | and neonatal | | | | | | patient | patient | | | | | Thermometer | Skin (mainly | Skin, oesophagus | Esophageal, | Oral, axillary or | Similar | | type | axilla), oral, | or the rectum. | rectal and | rectal body sites | | | | rectal and | | nasopharyngeal | | | | | nasopharyngeal cavity | | | | | | Prescription or OTC | Prescription | Prescription | / | / | Same | | Single use | Yes | Yes | / | / | Same | | Components | Disposable Temperature Probe is composed of plug, cable and temperature sensing probe. | Mainly composed of a plug connected to a patient monitor and a thermistor on the patient end. | / | / | Similar | | Sensor | Thermistor which is sensitive to temperature change. | Thermistor which is sensitive to temperature change. | / | / | Same | | Monitoring System Compatibility | Model C30 (Manufacturer: COMEN) | Dräger and Siemens patient monitoring systems. | / | / | Different Note 1 | | Principle of operation | The Disposable Temperature Probe obtains temperature information through the influence degree that the thermal balance has on the resistance value of thermistor sensor after it has contacted human body. | The thermistor consists of a resistor which is sensitive to temperature changes. | / | / | Similar | | Device specifications | 750±50mm or 750±20mm 8.9g (Body surface type), 13.1g (Celomic type) | / | / | / | Different Note 2 | | Temperature range | 25°C-45°C | 25°C-45°C | / | / | Same | | Accuracy | ±0.1°C (25°C - 45°C) | ±0.1°C (25°C - 45°C) | / | / | Same | | Ambient temperature environment | 5°C-40°C | Not specified. | / | / | Similar Note 3 | | Materials | Foam and PVC | Stainless steel, / thermoplastic elastomers, thermoplastic Polyolefin. | / | / | Different Note 4 | | Biocompatibility | Passed the tests as per ISO 10993-5 and ISO 10993-10 (Cytotoxicity, sensitization, irritation) | Passed the tests / as per ISO 10993-5 and ISO 10993-10 | / | / | Same | | Electrical safety | Passed the test as per IEC 60601-1 | Passed the test as / per IEC 60601-1 | / | / | Same | | EMC | Passed the test as per IEC 60601-1-2 | Passed the test as / per IEC 60601-1-2 | / | / | Same | | Sterility | Non-sterile | Non-sterile | / | / | Same | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ SHENZHEN LAUNCH ELECTRICAL CO., LTD 510(k)s - Section 7. 510 (k) Summary A Note 1: Although compared with the predicate device, the subject device may be used with different monitors, all related safety and performance tests have been conducted and met requirements, so this difference does not raise any device performance issues. A Note 2: Although the device specifications may be different from that of the predicates, this difference does not raise any product problems. A Note 3: The ambient temperature environment of the predicate device are not specified or not exactly the same. According to ISO 80601-2-56, a clinical thermometer shall operate in normal use over the ranges of an ambient temperature operating range from 15℃ to 35℃. The ambient temperature of the subject device covers this range, our company has also tested the subject device according to ISO 80601-2-56, which has proved that the subject device functions well under specified ambient temperature environment. A Note 4: The materials used in the subject device are different from that of the predicate device. But regarding biocompatibility, our company has authorized a qualified third-party lab to conduct tests according to ISO 10993-5 and ISO 10993-10, which has proved that the materials used in the subject device are biologically safe. {9}------------------------------------------------ > Note 5: Although the predicate device is intended for patient skin temperature measurement, the reference devices are intended for temperature measurement via nasopharynx and oral route. The method of measurement do not raise new or different questions of safety or effectiveness. ### (8) Non-clinical studies and tests performed Non-clinical testings have been conducted to verify that the Disposable Temperature Probe meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate devices. The testing results demonstrate that the targeted device complies with the following standards: - A IEC 60601-1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance - > IEC 60601-1-2. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests - > ISO 80601-2-56, Medical Electrical Equipment - Part 2-56: Particular Requirements For Basic Safety And Essential Performance Of Clinical Thermometers For Body Temperature Measurement. (General Plastic Surgery/General Hospital) The body-contacting components of this device are sticker and probe which have been demonstrated conformance to the following standards. - > ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For InVitro Cytotoxicity - A ISO 10993-10. Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization - > Cleaning validation and disinfection validation have been conducted based on the following FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." #### (9) Conclusion Based on the above analysis and tests performed, it can be concluded that the performance and function of Disposable Temperature Probe is Substantially Equivalent (SE) to the predicate device.