DeviceClearance

Product code FLL— General Hospital

Infrared Thermometer

Classification name
Continuous Measurement Thermometer
Device class
Class 2
Regulation
21 CFR 880.2910
Advisory panel
General Hospital
Total cleared
798
First cleared
Most recent

FDA classification definition

“A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.”

— U.S. Food and Drug Administration, device classification record for product code FLL under 21 CFR 880.2910, via openFDA

Market context for product code FLL

FDA has cleared 798 devices under product code FLL between 1976 and 2026, filed by 424 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code FLL

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 →

Recent clearances under product code FLL

1–100 of 798

Data sourced from openFDA. This site is unofficial and independent of the FDA.