Kaz USA, Inc., A Helen of Troy Company: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Kaz USA, Inc., A Helen of Troy Company” (first 2016, latest 2022), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 134 days. Since 2017 the median was 134 days, against 207 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 2 | 100 |
| 2017 | 1 | 127 |
| 2018 | 3 | 92 |
| 2019 | 0 | — |
| 2020 | 1 | 159 |
| 2021 | 0 | — |
| 2022 | 1 | 141 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Kaz USA, Inc., A Helen of Troy Company took a median 134 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 207 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 7 | 7 |
| QDD | Self-Fitting Air-Conduction Hearing Aid, Prescription | 1 | 1 |
Review panels
Most recent Kaz USA, Inc., A Helen of Troy Company 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212609 | BHA100 Series Braun Clear Hearing Aid | QDD | 2022-01-05 | 141 |
| K193213 | Vicks VNT200 No Touch Forehead Thermometer | FLL | 2020-04-28 | 159 |
| K180131 | Vicks RapidRead Digital Thermometer | FLL | 2018-08-14 | 209 |
| K181242 | Braun BNT400 No Touch + Forehead Thermometer | FLL | 2018-07-23 | 74 |
| K181015 | Braun BFH175 Infrared Forehead Thermometer | FLL | 2018-07-18 | 92 |
| K163516 | Braun No Touch + Forehead NTF3000 Thermometer | FLL | 2017-04-21 | 127 |
| K161933 | The Braun ThermoScan® 3 High Speed Compact Ear Thermometer | FLL | 2016-08-16 | 33 |
| K152975 | VDT985US Vicks SmartTemp Thermometer | FLL | 2016-03-23 | 167 |
Recalls
openFDA lists no recalls under a recalling firm named Kaz USA, Inc., A Helen of Troy Company.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Kaz USA, Inc., A Helen of Troy Company?
FDA lists 8 510(k) clearances under the applicant name “Kaz USA, Inc., A Helen of Troy Company” (first 2016, latest 2022), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Kaz USA, Inc., A Helen of Troy Company?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kaz USA, Inc., A Helen of Troy Company is 134 days. Since 2017: 134 days, versus 207 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Kaz USA, Inc., A Helen of Troy Company?
The most frequent FDA product codes under this applicant name are FLL (Continuous Measurement Thermometer, 7); QDD (Self-Fitting Air-Conduction Hearing Aid, Prescription, 1).
Next steps
- See all 8 Kaz USA, Inc., A Helen of Troy Company clearances with predicates and recalls
- Run predicate analysis for product code FLL, Kaz USA, Inc., A Helen of Troy Company's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.