Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Advanced Medical Solutions, Ltd. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
148 daysmedian FDA review time
347 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213473 | Antimicrobial Gelling Fiber Dressing with PHMB | Advanced Medical Solutions, Ltd. | 2023-10-26 | 728 | 0 |
| K210974 | High Performance Antimicrobial Gelling Fiber with Silver | Advanced Medical Solutions, Ltd. | 2021-05-12 | 41 | 0 |
| K190819 | Silicone PHMB Foam Wound Dressing | Advanced Medical Solutions, Ltd. | 2019-07-25 | 115 | 0 |
| K183645 | Silver High Performance Dressing | Advanced Medical Solutions, Ltd. | 2019-05-29 | 154 | 1 |
| K180634 | Surgical Silver Post Operative Dressing | Advanced Medical Solutions, Ltd. | 2018-08-07 | 148 | 0 |
| K181197 | PHMB Foam Wound Dressing | Advanced Medical Solutions, Ltd. | 2018-08-03 | 88 | 0 |
| K163062 | PHMB Antimicrobial Foam Wound Dressing | Advanced Medical Solutions, Ltd. | 2017-07-25 | 265 | 0 |
| K032742 | SILVER FOAM WOUND DRESSING | Advanced Medical Solutions, Ltd. | 2004-08-16 | 347 | 0 |
| K041316 | ANTIMICROBIAL ALGINATE DRESSING | Advanced Medical Solutions, Ltd. | 2004-08-05 | 80 | 0 |
| K024298 | ANTIMICROBIAL ALGINATE DRESSING | Advanced Medical Solutions, Ltd. | 2003-06-30 | 188 | 0 |
| K010245 | ACTIVHEAL SCAR MANAGEMENT DRESSING | Advanced Medical Solutions, Ltd. | 2001-04-25 | 90 | 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