FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Radius T wearable thermometer
K Number: K203215
·
Decision Jun 11, 2021
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
85
Review Days
221
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Radius T wearable thermometer
- K Number
- K203215
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Masimo Corporation
- Date Received
- November 2, 2020
- Decision Date
- June 11, 2021
- Product Code
- FLL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FLL), ordered by most recent decision date.
Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)
FDA 510(k)
FDA Class 2
·General Hospital
Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
FDA 510(k)
FDA Class 2
·General Hospital
Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)
FDA 510(k)
FDA Class 2
·General Hospital
Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)
FDA 510(k)
FDA Class 2
·General Hospital
YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
FDA 510(k)
FDA Class 2
·General Hospital
Infrared Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Masimo Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K254209 | Radius VSM and Accessories | Jun 4, 2026 | Substantially Equivalent |
| K243324 | Masimo O3 Regional Oximeter | Jul 17, 2025 | Substantially Equivalent |
| K250757 | Radius VSM and Accessories | May 29, 2025 | Substantially Equivalent |
| K243305 | Masimo W1 | Apr 3, 2025 | Substantially Equivalent |
| K240229 | Masimo W1 | Aug 8, 2024 | Substantially Equivalent |
| K234021 | Masimo Stork | May 3, 2024 | Substantially Equivalent |
| K214115 | MightySat -OTC | Jan 31, 2024 | Substantially Equivalent |
| K223721 | Masimo Stork | Dec 15, 2023 | Substantially Equivalent |
| K232512 | Masimo W1 | Nov 17, 2023 | Substantially Equivalent |
| DEN200076 | ORi | Oct 12, 2023 | Unknown |