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FDA PRODUCT CODE · CLASS II

FLL — Continuous Measurement Thermometer

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 880.2910
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
11
510(K)/PMA CLEARANCES
510k: 11
0
RECALL ENTRIES

Recent clearances

K253162Unimed Medical Supplies, Inc. · 510k2026-06-05
K251160Shenzhen Med-Link Electronics Tech Co., Ltd. · 510k2026-01-08
K250470Shenzhen AOJ Medical Technology Co., Ltd. · 510k2025-06-23
K243000Shenzhen Medke Technology Co., Ltd. · 510k2025-06-20
K250878Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 510k2025-05-22
K243082Guangzhou Daxin Health Technology Co., Ltd. · 510k2025-04-25
K250401Aion Biosystems, Inc. · 510k2025-03-14
K243136Shenzhen Finicare Co., Ltd. · 510k2025-02-14

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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