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
| Country | Makers |
|---|---|
| United States | 10 |
| China | 7 |
| Mexico | 2 |
| South Korea | 1 |
| India | 1 |
| Hong Kong | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| American Thermal Instruments, LLC | Dayton, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing ZKSK Technology Co., Ltd. | beijing, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gfa Production Inc | Clearwater, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Genial Technology Co., Ltd. | Zhaoqing Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HUMETRON Co. | Cheongju Chungbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huzhou Junda Industry Co., Ltd. | Anji Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Indicators, Inc. | Hamilton, NJ, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Risenmed Technology Co.,ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Tianbo First Aid Product Co., Ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onbo Electronic (shenzhen) Co. Ltd. | SHENZHEN Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| P Bhogilal Pvt Ltd | Kolkata West Bengal, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Urologos De Mexico S.A. De C.V. | MEXICALI Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rallinson Corp | Miami, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rci Hudson De Mexico S. De RL. De CV. | Nuevo Laredo Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Bairunheng Technology Co., Ltd. | shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Us LLC | Eagan, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Gilbert Group LLC | Chicago, IL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| TVP Developments Ltd | Kowloon, Hong Kong | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Titronics Research & Development | Tiffin, IA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.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.