Temperature probes (5 models)— 510(k) K253162
Substantially EquivalentUnimed Medical Supplies, Inc.
FDA 510(k) clearance K253162 for Temperature probes (5 models), Substantially Equivalent on 2026-06-05. Applicant: Unimed Medical Supplies, Inc.. Device class: 2.
Clearance details
- Device name as filed
- Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)
- Applicant
- Unimed Medical Supplies, Inc.
- Product code
- Code FLL
- Device class
- Class 2
- Regulation
- 21 CFR 880.2910
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code FLL
view all- K251160 — Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
- K250470 — Ear Thermometer (3 models)
- K243000 — Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)
- K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
- K243082 — Infrared Thermometer
More clearances from Unimed Medical Supplies, Inc.
view all- K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
- K253964 — Disposable Neonatal NIBP Cuff (U1681S-C51N)
- K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (4 models)
- K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48) +1 more
- K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (5 models)
Adverse events under product code FLL
product code FLL- Death
- 3
- Malfunction
- 557
- Total
- 560
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.