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 Olive Branch, MS, United States, 29 510(k) clearances
Kaz USA, Inc., A Helen of Troy Company is registered with the FDA (registration 3010405299) in Olive Branch, MS, United States. It lists 7 device types. The FDA files 29 510(k) clearances under its listings, the newest dated August 21, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3010405299
- Address
- 7159 Polk Lane, Olive Branch, MS, United States, 38654
- Owner or operator
- Kaz USA, Inc., A Helen of Troy Company (1314800)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 19, 2007
- 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, BUA6120US and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cleaner, Air, Medical Recirculating | FRF | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Clinical Electronic Thermometer | SDV | 2 | Repackager or relabeler | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Flowmeter, Blood, Cardiovascular | DPW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Repackager or relabeler | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
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 |
| 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 |
| 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 |
| December 9, 2004 | K043110 | MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1 | 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 |
| 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 |
| August 25, 1994 | K940573 | HEPA AIR CLEANER | FRF | Substantially Equivalent | Duracraft Corp. | accessdata.fda.gov |
| December 7, 1987 | K872359 | ENVIRACAIRE MODEL EV-1 | FRF | Substantially Equivalent | Enviracaire Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of Clinical Electronic Thermometer
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Flowmeter, Blood, Cardiovascular
- All makers of Cleaner, Air, Medical Recirculating
- All makers of Humidifier, Non-Direct Patient Interface (Home-Use)
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.