Data / Medical devices / United States / Kaz USA, Inc., A Helen of Troy Company
Kaz USA, Inc., A Helen of Troy Company: FDA-registered device maker in Marlborough, MA, United States, 34 510(k) clearances
Kaz USA, Inc., A Helen of Troy Company is registered with the FDA (registration 3006169981) in Marlborough, MA, United States. It lists 11 device types. The FDA files 34 510(k) clearances under its listings, the newest dated August 21, 2024. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3006169981
- Address
- 400 Donald Lynch Blvd Ste 300, Marlborough, MA, United States, 01752
- Owner or operator
- Kaz USA, Inc., A Helen of Troy Company (1314800)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- June 24, 1992
- Registered through
- 2026
- Brand names listed
- 6' Tether for PRO 6000, 9' Tether for PRO6000, BRAUN EXACTFIT 3 UPPER ARM BLOOD PRESSURE MONITOR, BRAUN ExactFit 1 Upper arm blood pressure monitor, BRAUN ExactFit 2 connect Upper arm Blood pressure monitor, BRAUN NO TOUCH THERMOMETER, BRAUN Sensian 4 3-in-1 Thermometer, BRAUN ThermoScan 4+ connect Ear thermometer and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 21, 2024 | K241351 | Blood Pressure Monitor (TMB-2092-G) | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| November 28, 2023 | K232713 | Blood Pressure Monitor | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| April 10, 2023 | K222887 | Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor | DXN | Substantially Equivalent | Famidoc Technology Company Limited | accessdata.fda.gov |
| April 28, 2020 | K193213 | Vicks VNT200 No Touch Forehead Thermometer | FLL | Substantially Equivalent | Kaz USA, Inc., A Helen of Troy Company | accessdata.fda.gov |
| November 27, 2019 | K191673 | Upper Arm Blood Pressure Monitor | DXN | Substantially Equivalent | Famidoc Technology Company Limited | accessdata.fda.gov |
| August 14, 2018 | K180131 | Vicks RapidRead Digital Thermometer | FLL | Substantially Equivalent | Kaz USA, Inc., A Helen of Troy Company | accessdata.fda.gov |
| July 23, 2018 | K181242 | Braun BNT400 No Touch + Forehead Thermometer | FLL | Substantially Equivalent | Kaz USA, Inc., A Helen of Troy Company | accessdata.fda.gov |
| July 23, 2018 | K171888 | Non-contact infrared body thermometer | FLL | Substantially Equivalent | Hetaida Technology Co., Ltd. | accessdata.fda.gov |
| July 18, 2018 | K181015 | Braun BFH175 Infrared Forehead Thermometer | FLL | Substantially Equivalent | Kaz USA, Inc., A Helen of Troy Company | accessdata.fda.gov |
| April 21, 2017 | K163516 | Braun No Touch + Forehead NTF3000 Thermometer | FLL | Substantially Equivalent | Kaz USA, Inc., A Helen of Troy Company | accessdata.fda.gov |
| August 16, 2016 | K161933 | The Braun ThermoScan® 3 High Speed Compact Ear Thermometer | FLL | Substantially Equivalent | Kaz USA, Inc., A Helen of Troy Company | accessdata.fda.gov |
| March 23, 2016 | K152975 | VDT985US Vicks SmartTemp Thermometer | FLL | Substantially Equivalent | Kaz USA, Inc., A Helen of Troy Company | accessdata.fda.gov |
| March 1, 2016 | K152748 | Braun Thermoscan PRO 6000 Ear Thermometer | FLL | Substantially Equivalent | Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc) | accessdata.fda.gov |
| May 21, 2014 | K134043 | NO TOUCH+FOREHEAD NTF 3000 THERMOMETER | FLL | Substantially Equivalent | Kaz USA, Inc (A Subsidiaryof Kaz Inc) | accessdata.fda.gov |
| January 31, 2012 | K120058 | TRANSTEK BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Zhongshan Transtek Electronics Co., Ltd. | accessdata.fda.gov |
| June 6, 2011 | K103839 | BEHIND EAR GENTLE TOUCH THERMOMETER | FLL | Substantially Equivalent | Kaz, Inc. | accessdata.fda.gov |
| May 27, 2011 | K101681 | TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995 | DXN | Substantially Equivalent | Zhongshan Transtek Electronics Co., Ltd. | accessdata.fda.gov |
| January 26, 2011 | K103800 | BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS | FLL | Substantially Equivalent | Kaz USA, Inc (A Subsidiaryof Kaz Inc) | accessdata.fda.gov |
| December 29, 2010 | K103097 | INFRARED EAR THERMOMETER | FLL | Substantially Equivalent | Radiant Innovation, Inc. | accessdata.fda.gov |
| August 4, 2010 | K101747 | BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES MODEL 6021791-PRO 4000 SERIES, 6022790-IRT 4000 SE | FLL | Substantially Equivalent | Kaz USA, Inc (A Subsidiaryof Kaz Inc) | accessdata.fda.gov |
| January 31, 2006 | K060006 | BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER | FLL | Substantially Equivalent | Braun GmbH | accessdata.fda.gov |
| October 26, 2005 | K052849 | INFRARED THERMOMETER, FDIR-V1 | FLL | Substantially Equivalent | Famidoc Technology Co., Ltd. | accessdata.fda.gov |
| May 11, 2005 | K051100 | MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| December 9, 2004 | K043110 | MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1 | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| February 23, 2004 | K033820 | MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1 | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| October 24, 2003 | K031928 | BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT) | FLL | Substantially Equivalent | Braun GmbH | accessdata.fda.gov |
| September 23, 2003 | K032364 | MICROLIFE DIGITAL UNDERARM ELECTRONIC THERMOMETER, MODEL MT 18E1 (V932) | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| July 27, 2001 | K012035 | BRAUN PRECISION SENSOR PRO, MODEL BP 2590 | DXN | Substantially Equivalent | Braun GmbH | accessdata.fda.gov |
| May 16, 2001 | K003732 | BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES | DXN | Substantially Equivalent | Braun GmbH | accessdata.fda.gov |
| October 20, 1999 | K992468 | BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER | FLL | Substantially Equivalent | Braun GmbH | accessdata.fda.gov |
| March 15, 1999 | K983295 | BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/3520 | FLL | Substantially Equivalent | Braun AG | accessdata.fda.gov |
| April 30, 1998 | K970211 | MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR | DPW | Substantially Equivalent | Micro Weiss Electronics | accessdata.fda.gov |
| February 10, 1995 | K950116 | THERASTEAM PERSONAL STEAM INHALER | KFZ | Substantially Equivalent | Kaz, Inc. | accessdata.fda.gov |
| May 23, 1985 | K851146 | DIGITAL THERMOMETER | FLL | Substantially Equivalent | Micro Idea Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Irrigator, Powered Nasal
- All makers of Oximeter, Infrared, Sporting, Aviation
- All makers of Humidifier, Non-Direct Patient Interface (Home-Use)
- All makers of Clinical Electronic Thermometer
Updated August 21, 2024. 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.