Who is the manufacturer of Reusable Temperature Probe, Disposable Temperature Probe?

Shenzhen Sino-K Medical Technology Co.,Ltd filed the 510(k) submission for Reusable Temperature Probe, Disposable Temperature Probe (K223807).

What is the FDA product code for Reusable Temperature Probe, 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 Reusable Temperature Probe, Disposable Temperature Probe?

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

Who can help prepare an FDA 510(k) submission like Reusable Temperature Probe, 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.

Reusable Temperature Probe, Disposable Temperature Probe

K223807 · Shenzhen Sino-K Medical Technology Co.,Ltd · FLL · Aug 25, 2023 · General Hospital

Device Facts

Record ID	K223807
Device Name	Reusable Temperature Probe, Disposable Temperature Probe
Applicant	Shenzhen Sino-K Medical Technology Co.,Ltd
Product Code	FLL · General Hospital
Decision Date	Aug 25, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.2910
Device Class	Class 2
Attributes	Pediatric

Intended Use

Reusable Temperature Probes: Reusable Temperature Probes are intended to be used for monitoring temperature for multi-patient use. The temperature probes are reusable and designed for use with monitor of GE-Marquette Model DASH3000. These devices are used by qualified medical professionals only. Disposable Temperature Probes: Disposable Temperature Probes are intended to be used for monitoring temperature for single patient use. The temperature probes are non-sterile and designed for use with monitors of GE- Marquette Model DASH3000. These devices are used by qualified medical professionals only.

Device Story

Device consists of temperature probes (reusable or disposable) with a connector for GE-Marquette DASH3000 monitors and a thermistor at the patient end. Principle of operation: resistance-based sensing using a Negative Temperature Coefficient (NTC) thermistor; resistance increases as temperature decreases, providing linear temperature measurement. Used in healthcare facilities by qualified medical professionals for patient temperature monitoring. Output is displayed on the compatible monitor to assist clinicians in patient assessment. Benefits include accurate, continuous temperature monitoring for clinical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-5, ISO 10993-10), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance testing (ISO 80601-2-56).

Technological Characteristics

NTC thermistor-based sensing. Reusable models: PVC cable, steel/epoxy/PA66 probe end. Disposable models: PVC cable, epoxy/medical pressure-sensitive adhesive probe end. Measurement range 25-45°C; accuracy ±0.1°C. Compatible with GE-Marquette DASH3000. Non-sterile. Complies with IEC 60601-1, IEC 60601-1-2, ISO 80601-2-56, and ASTM D4169-22.

Indications for Use

Indicated for monitoring patient body temperature in clinical settings. Suitable for adult and pediatric populations. Reusable probes for multi-patient use; disposable probes for single-patient use. Designed for use with GE-Marquette Model DASH3000 monitors by qualified medical professionals.

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

Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes (K193338)

Related Devices

K193338 — Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes · Shenzhen Med-Link Electronics Tech Co., Ltd. · Aug 25, 2020
K203636 — PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS; Rectum Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AG · Jkh USA, LLC · Aug 31, 2021
K182667 — Med-link Temperature Probes · Shenzhen Med-Link Electronics Tech Co., Ltd. · Jun 18, 2019
K251160 — Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) · Shenzhen Med-Link Electronics Tech Co., Ltd. · Jan 8, 2026
K050837 — REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE · GE Healthcare · Apr 27, 2005

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 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. August 25, 2023 Shenzhen SINO-K Medical Technology Co., Ltd. % Kevin Wang Consultant Shenzhen Chonconn Medical Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China Re: K223807 Trade/Device Name: Reusable Temperature Probe, Disposable Temperature Probe Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: July 25, 2023 Received: July 26, 2023 Dear Kevin Wang: 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. 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 {1}------------------------------------------------ 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, Porsche Bennett Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223807 Device Name Reusable Temperature Probe, Disposable Temperature Probe Indications for Use (Describe) Reusable Temperature Probes: Reusable Temperature Probes are intended to be used for monitoring temperature for multi- patient use. The temperature probes are reusable and designed for use with monitor of GE-Marquette Model DASH3000. These devices are used by qualified medical professionals only. Disposable Temperature Probes: Disposable Temperature Probes are intended to be used for monitoring temperature for single patient use. The temperature probes are non-sterile and designed for use with monitors of GE- Marquette Model DASH3000. These devices are used by qualified medical professionals only. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) 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}------------------------------------------------ # 510(K) Summary - K223807 ### Prepared in accordance with the requirements of 21 CFR Part 807.92 ## Prepared Date: August 25, 2023 ### 1. Submission sponsor Name: Shenzhen SINO-K Medical Technology Co., Ltd. Room401, Bldg2, Veteran Ind. City, Gongle Community, Xixiang Street, Baoan District, Shenzhen, Guangdong, China Contact person: Lao Chengxin Title: General Manager E-mail: boss(@sino-k.com Tel: +86 137 15333326 ### Submission correspondent 2. Name: Shenzhen Chonconn Medical Device Consulting Co., Ltd. Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China Contact person: Kevin Wang E-mail: kevin(@chonconn.com Tel: +86-755 33941160 ### 3. Subject Device Information | Trade/Device Name | Reusable Temperature Probe, Disposable Temperature Probe | |---------------------------|----------------------------------------------------------| | Regulatory Class | Class II | | Regulation Number | 21CFR 880.2910 | | Regulation/Common Name | Clinical Electronic Thermometer | | Product Code | FLL | | Submission type | Traditional 510(K) | ### Predicate Device 4. | Manufacturer Name | Shenzhen Med-link Electronics Tech Co., Ltd. | |------------------------|------------------------------------------------------------------------------| | 510(k) Number | K193338 | | Trade/Device Name | Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes | | Regulatory Class | Class II | | Regulation Number | 21CFR 880.2910 | | Regulation/Common Name | Clinical Electronic Thermometer | | Product Code | FLL | | Submission type | Traditional 510(K) | {4}------------------------------------------------ ### 5. Device Description The proposed devices are used for patient temperature measurement. The probes are reusable or disposable depending on the model. These probes consist of a connector on the monitor end and a thermistor on the patient end. The working principle is resistance based on the metal conductor increasing with temperature decrease, and the linear changes to the characteristics of the temperature measurement. The proposed devices are designed to be used in a healthcare facility and compatible with a monitor, GE-Marquette Model DASH3000. The six models have two types of structure designs corresponding to reusable and disposable use which consists of different materials. The Negative Temperature Coefficient (NTC) of the six models are identical. Reusable models ST1304, ST2304, ST3304, ST4304 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials. Disposable models ST5105A and ST6105A have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials. | No. | Model | Description | |-----|---------|----------------------------------------------------------------| | 1 | ST1304 | Skin contact Temperature Probe, adult, reusable | | 2 | ST2304 | Body cavity Temperature Probe, Esophageal, adult, reusable | | 3 | ST3304 | Skin contact Temperature Probe, pediatric, reusable | | 4 | ST4304 | Body cavity Temperature Probe, Esophageal, pediatric, reusable | | 5 | ST5105A | Skin contact Temperature Probe, adult, disposable | | 6 | ST6105A | Body cavity Temperature Probe, Esophageal, adult, disposable | ## 6. Indication for use Reusable Temperature Probes: Reusable Temperature Probes are intended to be used for monitoring temperature for multipatient use. The temperature probes are reusable and designed for use with monitor of GE-Marquette Model DASH3000. These devices are used by qualified medical professionals only. Disposable Temperature Probes: Disposable Temperature Probes are intended to be used for monitoring temperature for single patient use. The temperature probes are non-sterile and designed for use with monitors of GE-Marquette Model DASH3000. These devices are used by qualified medical professionals only. {5}------------------------------------------------ | Item | Subject Device, K223807 | Predicate Device, K193338 | Comparison | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Trade name | Reusable Temperature Probe, Disposable Temperature Probe | Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes | / | | 510(k) submitter | Shenzhen SINO-K Medical Technology Co., Ltd. | Shenzhen Med-link Electronics Tech Co., Ltd. | / | | 510(k) Number | K223807 | K193338 | / | | Models | Reusable adult/pediatric models: ST1304, ST2304, ST3304, ST4304 Disposable adult/pediatric models: ST5105A, ST6105A | Reusable pediatric models: W0003D,W0001C,W000 1D, W00008C,W00008D Disposable adult/pediatric models: W0001E, W0001F, W0099F, W0003E, W0003F | SE Note 1 | | Type of use | Prescription/Rx | Prescription/Rx | Same | | Indication for Use | Reusable Temperature Probes: Reusable Temperature Probes are intended to be used for monitoring temperature for multi- patient use. The temperature probes are reusable and designed for use with monitor of GE-Marquette Model DASH3000. These devices are used by qualified | Med-link Reusable Temperature Probes: Med-link Temperature Probes are intended to be used for monitoring temperature for multi- patient use. The temperature probes are reusable and designed for use with monitors of Philips Model IntelliVueMP50, Mindray Model PM-9000 and Drager Model | SE Note 1 | | Item | Subject Device, K223807 | Predicate Device, K193338 | Comparison | | | professional only. Disposable Temperature Probes: Disposable Temperature Probes are intended to be used for monitoring temperature for single patient use. The temperature probes are non-sterile and designed for use with monitors of GE- Marquette Model DASH3000. These devices are used by qualified medical professional only. | These devices are used by qualified medical professional only. Med-link Disposable Temperature Probes: Med-link Disposable Temperature Probes are intended to be used for monitoring temperature for single patient use. The temperature probes are non-sterile and designed for use with monitors of GE Model B20 and Philips Model IntelliVueMP50. These devices are used by qualified medical professional only. | | | Operating Principle | Resistance of thermistor based on the metal conductor increases with temperature decrease, and the linear changes to the characteristics of the temperature measurement. | Resistance of thermistor based on the metal conductor increases with temperature decrease, and the linear changes to the characteristics of the temperature measurement. | Same | | Measure site | Skin, Esophagus | Skin, Esophageal and Rectal | SE Note 2 | | Usage | Reusable, Disposable | Reusable, Disposable | Same | | Measurement Range | 25-45°C | 25-45°C | Same | | Measurement Time | 60s | 180s | SE Note 3 | | Accuracy | ±0.1°C | ±0.1°C | Same | | Components | plug, cable and temperature sensing | plug, cable and temperature sensing | Same | | Item | Subject Device, K223807 | Predicate Device, K193338 | Comparison | | | probe | probe | | | Thermistor resistance | 2.25KΩ@25°C | 2.25KΩ@25°C | Same | | Device Dimension | Reusable models:3m Disposable models: 0.8m | Unknown | SE Note 4 | | Material | Materials of reusable probe: Cable: PVC Probe end: Steel, Epoxy, PA66 Materials of disposable probe: Cable: PVC Probe end: Epoxy, Medical pressure- sensitive adhesive | Materials of reusable probe: Cable: TPU Probe end: Epoxy, S304 Stainless Steel; Materials of disposable probe: Cable: PVC Probe end: Epoxy, PVC | SE Note 5 | | Compatible Monitors | GE-Marquette Model DASH3000 | Reusable temperature probes are compatible with Philips Model IntelliVue MP50, Mindray Model PM- 9000, Drager Model Infinity Gamma XL, and disposable temperature probes are compatible with GE Model B20 and Philips Model IntelliVue MP50. | SE Note 1 | | Operating Environment | Temperature: +5 to+40°C Humidity: ≤80% (non-condensing) Atmospheric pressure : 86kPa ~ 106kPa | Temperature: +5°C~+40°C; Atmospheric Pressure: 86 kPa to 106 kPa Relative humidity range:0 % to 80 %, non-condensing (% RH) | Same | | Storage Environment | Temperature: -10°C to +40°C | Temperature: -10°C to +40°C | Same | | Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | Same | | Performance | ISO 80601-2-56 | ISO 80601-2-56 | Same | | Biocompatibility | All the patient-contacting materials are evaluated by the biocompatibility standard ISO10993-1 | All the patient-contacting materials are evaluated by the biocompatibility standard ISO10993-5, ISO 10993-10. | Same | | Sterilization | Non-sterile | Non-sterile | Same | | Operational Type | Continual | Continual | Same | | Shelf life | 2 years | Unknown | SE Note 6 | ### 7. Comparison to the Predicate Device {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ Note 1 The subject device is compatible with a different monitor than the predicate device. In addition, the intended patient population of both the subject device and the predicate device include adult and pediatric patient populations with the only difference being that The core component of the temperature probes in the subject devices is Negative Temperature Coefficient (NTC) which is identical to the NTC used in the predicate devices. The NTC determines the accuracy and range of temperature measurement. The subject device performance was tested in accordance with ISO 80601-2-56 for all models, using the compatible monitor. All results met the requirements. Therefore, the differences do not raise new questions of safety and effectiveness. ## Note 2 The subject device measurement sites are a subset of the predic sites. The subject device performance and biocompatibility was tested in accordance to ISO 80601-2-56 and ISO10993-1, respectively. Therefore, the difference does not raise new questions of safety and effectiveness. ## Note 3 The meas ne of the subject device is 60 seconds; he time of the predicate device is 180 seconds. The subject device's measurement time is le than that of the predicate and the device performance of all models have been tested to ISO80601-2-56. Therefore, the differences do not raise new or different questions of safet and effectiveness. ## Note 4 ns of the predicate device are unknown. The ide flexibility for clinical use. The length e of the subject devices. The performance o {9}------------------------------------------------ been verified with ISO 80601-2-56; the difference does not raise new questions of safety and effectiveness. ## Note 5 Although patient-contacting materials are different between the subject devices and predicate devices, all of the subject device models were tested in accordance to and complied with ISO 10993-5 and ISO 10993-10. Therefore, the differences do not raise new questions of safety and effectiveness. ## Note 6 The shelf life of the subject device is 2 years; however, the shelf life of the predicate device is unknown. The performance of the subject device has been verified for the claimed shelf life. Therefore, the difference does not raise new questions of safety and effectiveness. ### 8. Non- Clinical Testing The following testing was conducted to demonstrate substantial equivalence. # Biocompatibility testing The biocompatibility evaluation for the subject devices were conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests: - Cytotoxicity - o ISO10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity - . Sensitization - ISO10993-10 Third Edition 2010-08-01 Biological evaluation of medical 0 devices - Part 10: Tests for irritation and skin sensitization - Irritation . - ISO10993-10 Third Edition 2010-08-01 Biological evaluation of medical O devices - Part 10: Tests for irritation and skin sensitization - Oral mucosa Irritation (Body cavity Temperature Probe only) # Performance Testing Non-clinical testing has been conducted to verify that the subject devices meet all design specifications which support 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: - IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical {10}------------------------------------------------ Equipment- Part 1: General requirements for basic safety and essential performance - . IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests - ISO 80601-2-56:2017+A1:2018 Medical electrical equipment – Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement. - ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems ### 9. Clinical Testing No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device. ## 10. Conclusion It can be concluded that the differences between the subject devices, Reusable Temperature Probe, Disposable Temperature Probe and predicate devices do not raise new or different questions of safety or effectiveness. The subject device is substantially equivalent to the predicate device. Med-link Reusable Temperature Probes, Med- link Disposable Temperature Probes, cleared under K193338.