XINKANG MEDICAL INSTRUMENT CO. LTD.

FDA Device Registration & Listing · Shenzhen Guangdong, CN · Registration 3017953522

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017953522
FEI Number
3017953522
Entity Name
XINKANG MEDICAL INSTRUMENT CO. LTD.
City/State/Country
Shenzhen Guangdong, CN
Establishment Address
808, Building 6, Hengda Fashion Valley Building (East District), Fulong Road, Shanghenglang Community, Dalang Street, Longhua District, Shenzhen Guangdong 518100, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Xinkang Medical Instrument Co. Ltd. (Owner Number: 10078983)
Owner / Operator Contact Address
808, Building 6, Hengda Fashion Valley Building (East District), Fulong Road, Shanghenglang Community, Dalang Street, Longhua District, Shenzhen, CN-GD 518100, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Xinkang, HP 8Pin Reusable Adult Finger Clip Spo2 Sensor, model: XSNS2 Xinkang, Spacelabs 10Pin Reusable Pediatric Finger Clip Spo2 Sensor, model: XSNY1 Xinkang, HP 8Pin Reusable Pediatric Finger Clip Spo2 Sensor, model: XSNY2 Xinkang, NELLCOR 9Pin Reusable Pediatric Finger Clip Spo2 Sensor, model: XSNY3 Xinkang, BCI 9Pin Reusable Pediatric Finger Clip Spo2 Sensor, model: XSPF1 Xinkang, NELLCOR 9Pin Reusable Pediatric Silicone Soft Spo2 Sensor, model: XSIS3 Xinkang, BCI 9Pin Reusable Adult Finger Clip Spo2 Sensor, model: XSAF1 Xinkang, Nellcor 9pin Oximax Disposable Adult Blue Sponge Spo2 Sensor, model: XDBS Xinkang, NELLCOR 14Pin Reusable Adult Finger Clip Spo2 Sensor, model: XSAF2 Xinkang, Mindray T5 7Pin Reusable Adult Silicone Soft Spo2 Sensor, model: XSAS4 Xinkang, NELLCOR 14Pin Reusable Adult Silicone Soft Spo2 Sensor, model: XSAS2 Xinkang, Mindray T5 7Pin Reusable Pediatric Finger Clip Spo2 Sensor, model: XSPF4 Xinkang, Spacelabs 10Pin Reusable Pediatric Silicone Soft Spo2 Sensor, model: XSIS1 Xinkang, GE2500 11Pin Reusable Pediatric Finger Clip Spo2 Sensor, model: XSNY4 Xinakng, Nellcor 9pin Oximax Disposable Adult Non-woven Spo2 Sensor, model: XDAN Xinkang, HP 8Pin Reusable Adult Silicone Soft Spo2 Sensor, model: XSAE2 Xinkang, BCI 9Pin Reusable Pediatric Silicone Soft Spo2 Sensor, model: XSPS1 Xinkang, GE2500 11Pin Reusable Pediatric Silicone Soft Spo2 Sensor, model: XSIS4 Xinkang, Spacelabs 10Pin Reusable Adult Finger Clip Spo2 Sensor, model: XSNS1 Xinkang, BCI 9Pin Reusable Adult Silicone Soft Spo2 Sensor, model: XSAS1 Xinkang, GE2500 11Pin Reusable Adult Finger Clip Spo2 Sensor, model: XSNS4 Xinakng, Nellcor 9pin Oximax Disposable Adult L type Non-woven Spo2 Sensor, model: XDBN Xinkang, GE2500 11Pin Reusable Adult Silicone Soft Spo2 Sensor, model: XSAE4 Xinkang, HP 8Pin Reusable Pediatric Silicone Soft Spo2 Sensor, model: XSIS2 Xinkang, NELLCOR 9Pin Reusable Adult Silicone Soft Spo2 Sensor, model: XSAE3 Xinkang, Mindray 6Pin Reusable Adult Finger Clip Spo2 Sensor, model: XSAF3 Xinkang, Mindray 6Pin Reusable Adult Silicone Soft Spo2 Sensor, model: XSAS3 Xinkang, Mindray 6Pin Reusable Pediatric Finger Clip Spo2 Sensor, model: XSPF3 Xinkang, Mindray 6Pin Reusable Pediatric Silicone Soft Spo2 Sensor, model: XSPS3 Xinakng, Nellcor 9pin Oximax Disposable Pediatric Non-woven Spo2 Sensor, model: XDPN Xinkang, Spacelabs 10Pin Reusable Adult Silicone Soft Spo2 Sensor, model: XSAE1 Xinkang, Mindray T5 7Pin Reusable Adult Finger Clip Spo2 Sensor, model: XSAF4 Xinkang, NELLCOR 14Pin Reusable Pediatric Finger Clip Spo2 Sensor, model: XSPF2 Xinkang, NELLCOR 9Pin Reusable Adult Finger Clip Spo2 Sensor, model: XSNS3 Xinkang, Mindray T5 7Pin Reusable Pediatric Silicone Soft Spo2 Sensor, model: XSPS4 Xinkang, NELLCOR 14Pin Reusable Pediatric Silicone Soft Spo2 Sensor, model: XSPS2 ECG Cables and Leadwires, Model: G2202B10A, G2202C10A, G2202S10A, E2101C5A, E2101C3A, E2101S3A, E2101S5A

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQA Oximeter Cardiovascular Class 2 870.2700 2020-11-12
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2020-11-12

Official Correspondent

Changsheng Xu

US Agent Details

Thomas Tang Email: usagent@cefda.com Phone: (631) 7511103

Related Public Records

Same Entity

Xinkang Medical Instrument Co. Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23
K973147 Nellcor Puritan Bennett, Inc. NPB-295 PULSE OXIMETER 1997-11-14
K231243 Guangdong Genial Technology Co., Ltd. Finger Clip Pulse Oximeter 2023-10-31
K971628 Somanetics Corp. SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) 1997-10-10
K153184 Shenzhen Caremed Medical Technology Co., Ltd. Caremed Reusable & Disposable SPO2 Sensors 2017-01-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017953522. Last updated year: 2026. Please use registration number 3017953522 when referencing this establishment in official correspondence.
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