Kaz USA, Inc., A Helen of Troy Company
Marlborough, MA, US
Kaz USA, Inc., A Helen of Troy Company appears in FDA device records in Marlborough, MA. FDA records list 8 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Kaz USA, Inc., A Helen of Troy Company between 2016 and 2022. The busiest year on record is 2018, with 3. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 3 |
| 2020 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K212609 | BHA100 Series Braun Clear Hearing Aid | QDD | Substantially Equivalent | |
| K193213 | Vicks VNT200 No Touch Forehead Thermometer | FLL | Substantially Equivalent | |
| K180131 | Vicks RapidRead Digital Thermometer | FLL | Substantially Equivalent | |
| K181242 | Braun BNT400 No Touch + Forehead Thermometer | FLL | Substantially Equivalent | |
| K181015 | Braun BFH175 Infrared Forehead Thermometer | FLL | Substantially Equivalent | |
| K163516 | Braun No Touch + Forehead NTF3000 Thermometer | FLL | Substantially Equivalent | |
| K161933 | The Braun ThermoScan® 3 High Speed Compact Ear Thermometer | FLL | Substantially Equivalent | |
| K152975 | VDT985US Vicks SmartTemp Thermometer | FLL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006169981 | 3006169981 | Kaz USA, Inc., A Helen of Troy Company | 400 Donald Lynch Blvd Ste 300, MARLBOROUGH, MA 01752 US | 2026 | and 1 more, listed in full below |
| 3010405299 | 3010405299 | Kaz USA, Inc., A Helen of Troy Company | 7159 Polk Lane, Olive Branch, MS 38654 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FRFCleaner, Air, Medical Recirculating
- SDVClinical Electronic Thermometer
- FLLContinuous Measurement Thermometer
- DPWFlowmeter, Blood, Cardiovascular
- KFZHumidifier, Non-Direct Patient Interface (Home-Use)
- MDMInstrument, Manual, Surgical, General Use
- KMAIrrigator, Powered Nasal
- OCHOximeter, Infrared, Sporting, Aviation
- IMAPack, Heat, Moist
- IMEPack, Hot Or Cold, Reusable
- IRTPad, Heating, Powered
- QDDSelf-Fitting Air-Conduction Hearing Aid, Prescription
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain