# Kaz USA, Inc., A Helen of Troy Company

- Location (FDA's records): Marlborough, MA
- FDA decisions: 8 (2016–2022): 8 510(k) clearances
- Product codes: FLL (7), QDD (1)
- 510(k) review time since 2016: median 134 days, against 184 for FDA's reviews in the same codes and years (6 of 8 faster)
- Predicates its devices cite: 10 (4 its own); citations of its devices by later devices: 15 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Microlife Intellectual Property GmbH: 2 (https://510kreport.com/company/microlife-intellectual-property)
- Bose Corporation: 1 (https://510kreport.com/company/bose)
- Raiing Medical Company: 1 (https://510kreport.com/company/raiing-medical)
- Famidoc Technology Co., Ltd.: 1 (https://510kreport.com/company/famidoc-technology)
- Kaz USA, Inc (A Subsidiaryof Kaz Inc): 1 (https://510kreport.com/company/kaz-usa-a-subsidiaryof-kaz)

## Firms that cite its devices most
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.: 1 (https://510kreport.com/company/jiangsu-yuyue-medical-equipment-supply)
- Hearx SA (Pty), Ltd.: 1 (https://510kreport.com/company/hearx)
- Myhomedoc, Ltd.: 1 (https://510kreport.com/company/myhomedoc)
- Hetaida Technology Co., Ltd.: 1 (https://510kreport.com/company/hetaida-technology)
- Zhejiang Rongsheng Industrial Co., Ltd.: 1 (https://510kreport.com/company/zhejiang-rongsheng-industrial)
- Andon Health Co, Ltd.: 1 (https://510kreport.com/company/andon-health)
- Heitaida Technology Co., Ltd.: 1 (https://510kreport.com/company/heitaida-technology)
- Xiamen Ants Bro Technology Co., Ltd.: 1 (https://510kreport.com/company/xiamen-ants-bro-technology)

## Its most-cited devices
- K163516: Braun No Touch + Forehead NTF3000 Thermometer (2017), cited by 10
- K212609: BHA100 Series Braun Clear Hearing Aid (2022), cited by 2
- K181242: Braun BNT400 No Touch + Forehead Thermometer (2018), cited by 1
- K180131: Vicks RapidRead Digital Thermometer (2018), cited by 1
- K152975: VDT985US Vicks SmartTemp Thermometer (2016), cited by 1

## Recent decisions
- K212609: BHA100 Series Braun Clear Hearing Aid (Jan 5, 2022)
- K193213: Vicks VNT200 No Touch Forehead Thermometer (Apr 28, 2020)
- K180131: Vicks RapidRead Digital Thermometer (Aug 14, 2018)
- K181242: Braun BNT400 No Touch + Forehead Thermometer (Jul 23, 2018)
- K181015: Braun BFH175 Infrared Forehead Thermometer (Jul 18, 2018)
- K163516: Braun No Touch + Forehead NTF3000 Thermometer (Apr 21, 2017)
- K161933: The Braun ThermoScan® 3 High Speed Compact Ear Thermometer (Aug 16, 2016)
- K152975: VDT985US Vicks SmartTemp Thermometer (Mar 23, 2016)

Source page: https://510kreport.com/company/kaz-usa-a-helen-of-troy