510(k) K251160
- Device
- Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
- Applicant
- Shenzhen Med-Link Electronics Tech Co., Ltd.
- 510(k) number
- K251160
- Product code
- FLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-01-08
- Date received
- 2025-04-15
- Regulation
- 880.2910
- Classification name
- Continuous Measurement Thermometer
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Summer Xia
- Address
- Zone A Of 1st And 2nd Floor, And 3rd Floor, Bldg. A, # 7, Tongsheng Industrial Park Rd. Shanghenglang Community, Shenzhen CN 518109 518109
FDA Registration Numbers
- 3011875311
- 3016864576
- 3015140207
- 3011651103
- 3005951243
- 1066444
- 3008307705
- 2132111
- 3015109923
- 3007770159
- 3016701404
- 3027135885
- 3027285900
- 9680225
- 1650347
- 3007007790
- 1216677
- 3026264
- 1222304
- 3030447506
- 3010390468
- 3008716327
- 3012804266
- 1423537
- 2437780
- 1718850
- 3003887292
- 3014015501
- 3015142815
- 3043513123
- 3012302888
- 3008756507
- 3005841768
- 3033536319
- 3005905524
- 3008771621
- 3015529350
- 3028172072
- 3017406171
- 1066270
- 3017896172
- 3018514222
- 3024790242
- 3016075711
- 3021422553
- 3005083505
- 3027510187
- 3007413079
- 9613793
- 3010984687
- 3008973759
- 3027256461
- 3007603826
- 2518422
- 3042272797
- 8010482
- 3014848734
- 3034603279
- 2936999
- 3014579161
- 3000130829
- 2032273
- 3015542362
- 3008808082
- 3007048291
- 3013874291
- 3038610665
- 3024491912
- 1055808
- 9681837
- 3011898560
- 3004485927
- 9610816
- 3010383847
- 3014468707
- 3009889471
- 3015142935
- 3015136472
- 3008384335
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code FLL
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250470 | Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) | Shenzhen AOJ Medical Technology Co., Ltd. | 2025-06-23 |
| K243000 | Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) | Shenzhen Medke Technology Co., Ltd. | 2025-06-20 |
| K250878 | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2025-05-22 |
| K243082 | Infrared Thermometer | Guangzhou Daxin Health Technology Co., Ltd. | 2025-04-25 |
| K250401 | AION TempShield | Aion Biosystems, Inc. | 2025-03-14 |
| K243136 | Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) | Shenzhen Finicare Co., Ltd. | 2025-02-14 |
| K240333 | Wearable Digital Thermometer (T31) | Guangdong Genial Technology Co., Ltd. | 2024-10-30 |
| K240223 | FMT Disposable and Autoclavable Temperature Probes | Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi | 2024-10-25 |
| K240220 | Aulisa Temperature Module (TM0002) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2024-09-27 |
| K240077 | Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044) | Covidien | 2024-08-20 |
| K233280 | SteadyTemp | Steadysense GmbH | 2024-06-21 |
| K240648 | Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) | Radiant Innovation, Inc. | 2024-06-05 |
| K240109 | Medical electronic thermometer (FC01, FC02) | Zhuzhou Goldenhot Medical Technology Co., Ltd. | 2024-04-12 |
| K233192 | Wireless Smart Thermometer | Famidoc Technology Company Limited | 2024-04-05 |
| K230889 | Digital Thermometer | Wenzhou Yosun Medical Technology Co.,Ltd | 2024-04-03 |