Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
G & W Applied Science Laboratories — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K813249 | HELP-MATE | G & W Applied Science Laboratories | 1981-12-03 | 15 | 0 |
| K780805 | S/D 600 SPHYGMOMANOMETER AND PULSEMETER | G & W Applied Science Laboratories | 1978-06-06 | 26 | 0 |
| K780677 | 4600 RECORDER | G & W Applied Science Laboratories | 1978-05-17 | 23 | 0 |
| K780566 | HEALTH SEAT SYSTEM | G & W Applied Science Laboratories | 1978-04-21 | 15 | 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