Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GYA — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
21 daysmedian FDA review time
189 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K883869 | DERMTRODE | World Precision Instruments, Inc. | 1988-09-30 | 17 | 0 |
| K854396 | RUB E-Z | E-Z Instruments Co. | 1986-05-08 | 189 | 0 |
| K830877 | AP-CHECK | General Devices | 1983-06-08 | 82 | 0 |
| K820040 | SC-IT IMPEDANCE TESTER | Cadwell Laboratories, Inc. | 1982-01-28 | 21 | 0 |
| K781475 | ELECTRODE IMPEDANCE TESTER-MODEL 500 | Life-Tech Instruments, Inc. | 1978-09-07 | 10 | 0 |
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