Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Wr Medical Electronics Co. — Predicate Candidate Screening

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

176 daysmedian FDA review time
403 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K092809HRV ACQUIREWr Medical Electronics Co.2010-10-194030
K063560HILGER DUAL-STIM NERVE STIMULATORWr Medical Electronics Co.2007-01-05380
K000574IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTROWr Medical Electronics Co.2000-08-091690
K992874Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEMWr Medical Electronics Co.1999-11-18840
K910624CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4Wr Medical Electronics Co.1992-01-173390
K895838BRACKMANN EMG MONITORING SYSTEMWr Medical Electronics Co.1990-03-271760

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