Braun Thermoscan PRO 6000 Ear Thermometer— 510(k) K152748
Substantially EquivalentKaz USA, Inc (A Subsidiary of Helen of Troy, Inc)
FDA 510(k) clearance K152748 for Braun Thermoscan PRO 6000 Ear Thermometer, Substantially Equivalent on 2016-03-01. Applicant: Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc). Device class: 2.
Clearance details
- Applicant
- Kaz USA, Inc (A Subsidiary of Helen of Troy, 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
- Southborough, MA, US
Recent devices under product code FLL
view all- K253162 — Temperature probes (5 models)
- 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)
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 →
Recalls naming K152748
K-number listed on FDA's recall record- Z-2339-2024 — Braun Thermoscan¿ PRO 6000 Ear Thermometer
- Z-2482-2021 — Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adults in a professional use environment. Model: 6000
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152748.
Data sourced from openFDA. This site is unofficial and independent of the FDA.