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
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#
- 3007134734
- 3004112621
- 9616843
- 1723241
- 1430016
- 2183924
- 3005583357
- 3010097171
- 3007007790
- 3009001657
- 3008318433
- 1718850
- 3038295706
- 3003887292
- 3013557562
- 3032916632
- 3011654863
- 3017581269
- 3009617411
- 3006082230
- 3012302888
- 3008956776
- 1000137876
- 3030597679
- 3007502227
- 2437780
- 2111760
- 2011171
- 3019737388
- 3003687189
- 1218950
- 3027285900
- 9613304
- 1928237
- 3010317211
- 3008384335
- 3016901080
- 9615817
- 1062836
- 9681834
- 3015876
- 3004871905
- 3012134907
- 3013298431
- 3021422553
- 3004215929
- 3017406171
- 3011651103
- 3034603279
- 3011359729
- 3001570235
- 3004485927
- 3003591740
- 3015142815
- 3006610790
- 8032009
- 1720734
- 3003399181
- 3017643152
- 3003832357
- 3017894657
- 3015142935
- 3044174020
- 3005877899
- 3018094310
- 3036108847
- 3009540516
- 3013500228
- 3011919098
- 3006845687
- 3038610665
- 3008756507
- 8031509
- 3037724692
- 3013545943
- 3016866092
- 3032109
- 3012416077
- 3017520431
Source Documents#
Other 510(k) Records For Product Code FLL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253162 | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG) | Unimed Medical Supplies, Inc. | 2026-06-05 |
| 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 |