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Data / Medical devices / Thermometer, Clinical Color Change

Thermometer, Clinical Color Change (FQZ): 22 FDA-registered makers in 6 countries

22 establishments in 6 countries are registered with the FDA to make Thermometer, Clinical Color Change (product code FQZ, Class 1, 21 CFR 880.2900). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on January 13, 2012, and lists 2 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code
FQZ
Device class
1
Regulation
880.2900
Medical specialty
General Hospital

Makers by country

CountryMakers
United States10
China7
Mexico2
South Korea1
India1
Hong Kong1

Makers of Thermometer, Clinical Color Change

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
American Thermal Instruments, LLCDayton, OH, United StatesManufacturer0000api.fda.gov
Beijing ZKSK Technology Co., Ltd.beijing, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Gfa Production IncClearwater, FL, United StatesSpecification developer0000api.fda.gov
Guangdong Genial Technology Co., Ltd.Zhaoqing Guangdong, ChinaManufacturer0000api.fda.gov
HUMETRON Co.Cheongju Chungbuk, South KoreaManufacturer0000api.fda.gov
Huzhou Junda Industry Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Medical Indicators, Inc.Hamilton, NJ, United StatesManufacturer0010api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Ningbo Risenmed Technology Co.,ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Tianbo First Aid Product Co., Ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Onbo Electronic (shenzhen) Co. Ltd.SHENZHEN Guangdong, ChinaManufacturer0000api.fda.gov
P Bhogilal Pvt LtdKolkata West Bengal, IndiaManufacturer0000api.fda.gov
Productos Urologos De Mexico S.A. De C.V.MEXICALI Baja California, MexicoContract manufacturer0000api.fda.gov
Rallinson CorpMiami, FL, United StatesSpecification developer0000api.fda.gov
Rci Hudson De Mexico S. De RL. De CV.Nuevo Laredo Tamaulipas, MexicoManufacturer0000api.fda.gov
Shenzhen Bairunheng Technology Co., Ltd.shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Solventum Us LLCEagan, MN, United StatesSpecification developer0000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
The Gilbert Group LLCChicago, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
TVP Developments LtdKowloon, Hong KongExporter to the US, Specification developer0000api.fda.gov
Titronics Research & DevelopmentTiffin, IA, United StatesManufacturer0000api.fda.gov

Updated January 13, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.