Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Woodside Biomedical, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
401 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K020180 | RELIEFBAND DEVICE, MODELS RB-DL, RB-EL, RB-RL | Woodside Biomedical, Inc. | 2002-03-21 | 62 | 0 |
| K994387 | RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL | Woodside Biomedical, Inc. | 2000-03-16 | 79 | 0 |
| K983907 | RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R | Woodside Biomedical, Inc. | 1999-12-09 | 401 | 0 |
| K982967 | RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R | Woodside Biomedical, Inc. | 1999-02-23 | 182 | 0 |
| K982436 | RELIEFBAND NST DEVICE, MODEL #'S WB-2, WB-6 AND WB-R | Woodside Biomedical, Inc. | 1998-10-08 | 86 | 0 |
| K980333 | RELIEFBAND | Woodside Biomedical, Inc. | 1998-02-18 | 21 | 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