Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Waismed, Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
217 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211968 | NIO+ Adult | Waismed, Ltd. | 2021-07-22 | 28 | 1 |
| K190538 | NIO-I | Waismed, Ltd. | 2019-10-07 | 217 | 0 |
| K160805 | NIO-P | Waismed, Ltd. | 2016-06-23 | 92 | 0 |
| K142086 | NIO -INTRAOSSEOUS DEVICE | Waismed, Ltd. | 2014-08-28 | 28 | 1 |
| K062940 | BONE INJECTION GUN (B.I.G.) | Waismed, Ltd. | 2006-12-22 | 85 | 0 |
| K022415 | BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST | Waismed, Ltd. | 2002-10-11 | 79 | 0 |
| K981853 | BONE INJECTION GUN (B.I.G.) DEVICE | Waismed, Ltd. | 1998-11-17 | 175 | 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