Who is the manufacturer of Reusable & Disposable SpO2 Sensors?

Shenzhen Coreray Technology, Ltd. filed the 510(k) submission for Reusable & Disposable SpO2 Sensors (K173368).

What is the FDA product code for Reusable & Disposable SpO2 Sensors?

DQA. It is classified under 21 CFR 870.2700 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Reusable & Disposable SpO2 Sensors?

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

What are the predicate devices for Reusable & Disposable SpO2 Sensors?

Caremed Reusable & Disposable SpO2 Sensors (K153184); Solaris Reusable & Disposable SPO2 Sensors (K100077).

Who can help prepare an FDA 510(k) submission like Reusable & Disposable SpO2 Sensors?

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 & Disposable SpO2 Sensors

K173368 · Shenzhen Coreray Technology, Ltd. · DQA · Aug 31, 2018 · Cardiovascular

Device Facts

Record ID	K173368
Device Name	Reusable & Disposable SpO2 Sensors
Applicant	Shenzhen Coreray Technology, Ltd.
Product Code	DQA · Cardiovascular
Decision Date	Aug 31, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2700
Device Class	Class 2

Intended Use

Coreray Reusable SPO2 Sensor is intended to be used in hospital settings where patient care is offered by qualified healthcare personnel. The Reusable SPO2 Sensor is intended for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40kg.

Device Story

Reusable SpO2 sensor; consists of connector, cable, and finger clip sensor housing. Contains two-wavelength LEDs (red 660nm, infrared 905nm) and photodetector. Operates by measuring optical absorption of functional arterial hemoglobin. Used in hospital settings by qualified healthcare personnel. Connects between patient and compatible pulse oximeter monitor. Provides continuous, non-invasive SpO2 and pulse rate data to monitor. Output assists clinicians in assessing patient oxygenation status and heart rate, facilitating timely clinical intervention.

Clinical Evidence

Clinical validation performed per ISO 80601-2-61:2011 requirements. Testing conducted in the 70%-100% SaO2 range to validate SpO2 accuracy. No animal testing performed.

Technological Characteristics

Materials: ABS, TPU, silicone. Sensing: 2-wavelength optical absorption (Red 660nm±10nm, IR 905nm±10nm). Form factor: Reusable finger clip. Connectivity: Wired connection to compatible pulse oximeter. Standards: IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61, ISO 10993-5/10.

Indications for Use

Indicated for continuous non-invasive monitoring of functional oxygen saturation (SpO2) and pulse rate (PR) in adult patients weighing >40kg in hospital settings.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Predicate Devices

Caremed Reusable & Disposable SpO2 Sensors (K153184)
Solaris Reusable & Disposable SPO2 Sensors (K100077)

Related Devices

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K242580 — Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) · Unimed Medical Supplies, Inc. · Feb 6, 2025
K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29) · Unimed Medical Supplies, Inc. · Dec 1, 2025

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 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. Shenzhen Coreray Technology, Ltd. % Field Fu Consultant Shenzhen Joyantech Consulting Co., Ltd. Room 1122, International Mayor Communication Center No. 55 Shi Zhou Zhong Road Nanshan, Shenzhen 518100 CHINA Re: K173368 Trade/Device Name: Reusable SpO2 Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: July 24, 2018 Received: August 2, 2018 Dear Field Fu: 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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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, Image /page/1/Picture/6 description: The image shows the name "Todd D. Courtney -S" in black text. The text is positioned in front of a light blue FDA logo. The text is clear and easy to read, and the logo is a simple and recognizable design. The image is likely a nameplate or a document header. 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) K173368 Device Name Reusable SPO2 Sensor #### Indications for Use (Describe) Coreray Reusable SPO2 Sensor is intended to be used in hospital settings where patient care is offered by qualified healthcare personnel. The Reusable SPO2 Sensor is intended for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than 40kg. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------------------------------------------| | × 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}------------------------------------------------ Version: A/0 # SECTION 05 510(k) Summary # 5.1 Administrative Information | Date of Summary prepared | Aug. 24, 2017 | |----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer information | Company title: Shenzhen Coreray Technology Co., Ltd Company address: ChuangYe Technology Park, 1th Dong Huan Road, Longhua New District, Shenzhen, 510000 P.R China. P.C.:518109 Contact person: Simon Fan Phone: +86-755-28839229 Fax: +86-755-28839229 E-mail: manager@core-ray.com | | Submission Correspondent Image: Logo 卓远天成 | Shenzhen Joyantech Consulting Co., Ltd. Address: Room 1122, International Mayors Communication Centre, NO. 55 Shizhou middle road , Nanshan District, Shenzhen Contact person: Mr. Field Fu E-Mail: cefda13485@163.com | # 5.2 Device Information | Type of 510(k) submission: | Traditional | |-------------------------------|-----------------------| | Trade Name: | Reusable SpO2 Sensor | | Model: | CR001-3106A | | Classification name: | Pulse Oximeter Sensor | | Review Panel: | Cardiovascular | | Product Code: | DQA | | Device Class: | II | {4}------------------------------------------------ Regulation Number: | 870.2700 ## 5.3 Predicate Device Information | Sponsor: | Shenzhen Caremed Medical Technology Co., Ltd. | |----------------|-----------------------------------------------| | Device: | Caremed Reusable & Disposable SpO2 Sensors | | 510(K) Number: | K153184 | | Sponsor: | Solaris Medical Technology Inc | Medical Technology, Inc. Sponsor: Solaris Reusable & Disposable SPO2 Sensors Device: K100077 510(K) Number: | ### 5.4 Device Description The Reusable SPO2 Sensor is comprised of a connector and a cable which terminates into sensor housing. The sensor contains two specific wavelength LEDs and a photo detector assembled into the sensor housing which separate by one housing half and the other half. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. One type of sensor housing is described in this submission: Reusable finger clip sensor The sensor has a labeling and specifications designed for compatibility with a specific monitor. ### 5.5 Intended Use/ Indications for Use Coreray Reusable SPO2 Sensor is intended to be used in hospital settings where patient care is offered by qualified healthcare personnel. The Reusable SPO2 Sensor is intended for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40kg. {5}------------------------------------------------ # 5.6 Technological characteristics of the subject device compared to the predicate device # Predicate Device Information: | 510(K) No.: | K153184 | |------------------------|-------------------| | Common name: | Oximeter | | Classification name: | Oximeter | | Production regulation: | 21 CFR § 870.2700 | | Product code: | DQA | | Panel: | Cardiovascular | | 510(K) No.: | K100077 | |------------------------|-----------------------| | Common name: | Pulse Oximeter Sensor | | Classification name: | Oximeter | | Production regulation: | 21 CFR § 870.2700 | | Product code: | DQA | | Panel: | Cardiovascular | # Comparison to predicate device: | Comparison item | Subject Device Reusable and disposable SPO2 sensor | Predicate Device K153184 | Predicate Device K100077 | Remarks | | |---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------| | Product Code | DQA | DQA | DQA | same | | | Regulation Number | 870.2700 | 870.2700 | 870.2700 | same | | | Classification | II | II | II | | | | Intended use& Indication s for Use | Coreray Reusable SPO2 Sensor is intended to be | Caremed Reusable & Disposable SPO2 Sensors are | When used with a compatible patient monitor or a pulse | SE as K100077 | | | | used in hospital settings where patient care is offered by qualified healthcare personnel. The Reusable SPO2 Sensor is intended for continuous non- invasive | indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing | oximeter device, Solaris Medical Technology, Inc. reusable & disposable SpO2 sensors are intended to be used for continuous, non-invasive functional arterial oxygen | | | | | monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40kg. Prescription device. | greater than40kg and pediatric patients weighing 10 -50 kg. | saturation (SpO2) and pulse rate monitoring. Solaris Medical Technology, Inc. reusable multi-patient use SpO2 Soft Sensors, reusable multi- patient use SpO2 Finger Sensors, and disposable single patient use SpO2 Soft- finger Sensors are for use with adult/pediatric patients weighing greater than 40kg. Solaris Medical Technology, Inc. disposable single patient use SpO2 Adhesive Sensors are for use with adult patients | | | | | | | adult patients | | | | | | | greater than 40kg, pediatric patients weighing 10 - 40 kg, and infant (non-neonatal) patients weighing 3 - 15kg. Prescription device. | | | | Measurement Method | 2-wavelength Relative Optical Absorption | 2-wavelength Relative Optical Absorption | 2-wavelength Relative Optical Absorption | same | | | Light Emitting | Red: 660nm±10nm Infrared: 905nm±10nm | Red:660-666nm, Ired:880-950nm | Red:660-666nm, Ired:880-950nm | similar Within the range of the frequency of the predicate devices. | | | Signal Detection Method | Photodetector | Photodetector | Photodetector | same | | | SPO2 Accuracy | ±3% (70-100%) | ±3% (70-100%) | ±2% (70-100%) | same as K153184, and compliance with the ISO80601 1-2-61. | | | Pulse Rate Accuracy | ±3(30-250bpm) | ±3(30-250bpm) | ±3(30-250bpm) | same | | | Applied population | Adult (≥40Kg) | Adult(≥40Kg) Pediatric(10- 50Kg) | Adult(≥40Kg) Pediatric(10- 50Kg) Neonatal ( 3- | SE as K100077 | | | | | | | 10Kg ) | | | Measurement part | Fingers | Fingers or toes | Fingers or toes | Fingers or toes | SE | | Sterile | No | No | No | No | same | | Material | ABS, TPU, Silicone, | ABS, PVC, TPU, Silicone, sponge | ABS, PVC, TPU, Silicone, sponge | ABS, PVC, Silicone and 3M | similar Passed the biocompa tibility test. | | Biocompatibili ty | Cytotoxicity Irritation Sensitization | Cytotoxicity Irritation Sensitization | Cytotoxicity Irritation Sensitization | Cytotoxicity Irritation Sensitization | same | | Distal connector Design | clip | finger clip and sponge adhesive | finger clip and sponge adhesive | soft tip and textile adhesive | clip design same as K153184 | | Electrical Performance and Safety | IEC60601- 1,IEC60601-1- 2, ISO80601-2- 61,ISO10993- 5/10 | IEC60601- 1,IEC60601-1-2, ISO80601-2- 61,ISO10993- 5/10 | IEC60601- 1,IEC60601-1-2, ISO80601-2- 61,ISO10993- 5/10 | IEC60601- 1,IEC60601-1-2, ISO80601-2- 61,ISO10993- 5/10 | same | {6}------------------------------------------------ {7}------------------------------------------------ Version: A/0 {8}------------------------------------------------ Version: A/0 The subject device and the predicate device have the same intended use and similar technological characteristics; they both measure SpO2 values for the patients. Thus the subject device is substantially equivalent to the predicate devices. # 5.7 Brief discussion of the nonclinical tests Reusable SpO2 Sensor conforms to the following standards: 60601-1:2005+CORR.1:2006+CORR.2007+A1:2012 Medical IEC Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential {9}------------------------------------------------ Performance. IEC 60601-1-2: 2014 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests ISO 80601-2-61:2011 Medical Electrical Equipment - Part 2-61: Particular Requirements For Basic Safety And Essential Performance Of Pulse Oximeter Equipment ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity. ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization. # 5.8 Brief discussion of clinical tests Clinical testing is conducted for validation of SoO2 the Coreray Reusable & Disposable SpO2 Sensor. The Reusable SpO₂ Sensor was satisfied the requirements of FDA quidance and ISO 80601-2-61:2011 in the range of 70%-100%SaO2. # 5.9 Other information (such as required by FDA guidance/Test) Animal performance testing is not required and was not performed to demonstrate substantial equivalence of the Coreray Reusable SpO2 Sensor. # 5.10 Conclusions Based on the above information, we conclude the subject device, Reusable SpO2 Sensor, is substantially equivalent to the predicate device.