Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GWY — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
18 daysmedian FDA review time
49 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050313 | BIS SRS (SEMI-RESUABLE SENSOR) | Aspect Medical Systems, Inc. | 2005-02-24 | 15 | 0 |
| K942926 | NEURO-AIDE | Burke Neutech, Inc. | 1994-08-03 | 42 | 0 |
| K871167 | SENSITESTER | Dexin Pty. , Ltd. | 1987-04-01 | 8 | 0 |
| K851749 | 1-380 PINWHEEL (WARTENBERG) | Artiberia | 1985-06-13 | 49 | 0 |
| K780422 | PINWHEEL | Projects IN Health | 1978-04-04 | 18 | 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