Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Kaz USA, Inc., A Helen of Troy Company · Predicate Candidate Screening

8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

141 daysmedian FDA review time
209 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K212609BHA100 Series Braun Clear Hearing AidKaz USA, Inc., A Helen of Troy Company2022-01-051410
K193213Vicks VNT200 No Touch Forehead ThermometerKaz USA, Inc., A Helen of Troy Company2020-04-281590
K180131Vicks RapidRead Digital ThermometerKaz USA, Inc., A Helen of Troy Company2018-08-142090
K181242Braun BNT400 No Touch + Forehead ThermometerKaz USA, Inc., A Helen of Troy Company2018-07-23740
K181015Braun BFH175 Infrared Forehead ThermometerKaz USA, Inc., A Helen of Troy Company2018-07-18920
K163516Braun No Touch + Forehead NTF3000 ThermometerKaz USA, Inc., A Helen of Troy Company2017-04-211270
K161933The Braun ThermoScanĀ® 3 High Speed Compact Ear ThermometerKaz USA, Inc., A Helen of Troy Company2016-08-16330
K152975VDT985US Vicks SmartTemp ThermometerKaz USA, Inc., A Helen of Troy Company2016-03-231670

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda