Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
MSC · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
234 daysmedian FDA review time
328 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253662 | LIXI (LXOSFM1) | Luwi, LLC | 2026-07-14 | 236 | 0 |
| K212928 | Lorals | Brazen Goods Inc. Dba Lorals | 2022-04-22 | 220 | 0 |
| K212037 | SancDam Latex Oral Dam | Sanctuary Health Sdn. Bhd. | 2022-03-28 | 271 | 0 |
| K203727 | Harmony Latex Dam, Harmony Non-Latex Dam | Pamco Distributing, Inc. | 2021-08-05 | 227 | 0 |
| K091769 | TRUST DAM | Line One Laboratories, Inc. | 2010-02-05 | 234 | 0 |
| K990067 | SHEER GLYDE DAMS | Louise C. Myers | 1999-02-19 | 42 | 0 |
| K970577 | GLYDE DAM LOLLYES | Glyde USA, Inc. | 1998-01-08 | 328 | 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