# FLL: Continuous Measurement Thermometer

- Device class: 2; regulation: 21 CFR 880.2910; FDA's rule: 510(k) required
- FDA decisions: 798
- 510(k) review time 2021–2025: median 221 days (middle half 157–291)
- Recalls: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 16
- 2018: 35
- 2019: 22
- 2020: 21
- 2021: 43
- 2022: 24
- 2023: 17
- 2024: 13
- 2025: 6
- 2026: 2

## Most-cited predicates
- K011291: Temporalscanner Thermometer, Sensortouch (2001), cited by 17
- K163516: Braun No Touch + Forehead NTF3000 Thermometer (2017), cited by 10
- K191829: Microlife Non-Contact Infrared Forehead Thermometer (2020), cited by 9
- K983295: Braun Thermoscan IRT3020/3500 One Secons Ear Thermometer, Model IRT3020/3520 (1999), cited by 9
- K011059: Infared Ear Thermometer, Model TH8 Series (2001), cited by 8
- K134043: NO Touch+Forehead NTF 3000 Thermometer (2014), cited by 8
- K191251: Infared Thermometer (2019), cited by 7
- K983406: Sanitherm Oral Disposable Thermometer Sheaths for Mercury Thermometer, Senitherm Oral Disposable Thermometer Sheaths for (1998), cited by 7
- K121427: Unimed Temperature Probe (2012), cited by 7
- K181013: Fever Scout (2018), cited by 6

Source page: https://510kreport.com/product-code/FLL
Data by year (CSV): https://510kreport.com/product-code/FLL.csv