Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Abigo Medical AB · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
196 daysmedian FDA review time
328 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171225 | Sorbact Wound Dressing-Ribbon Gauze | Abigo Medical AB | 2017-08-21 | 117 | 0 |
| K153674 | Sorbact Foam Gentle Border, Sorbact Superabsorbent | Abigo Medical AB | 2016-07-01 | 193 | 0 |
| K100591 | SORBACT | Abigo Medical AB | 2011-01-24 | 328 | 0 |
| K063059 | SORBACT WOUND DRESSING | Abigo Medical AB | 2007-04-19 | 196 | 0 |
| K920840 | OTOVENT | Abigo Medical AB | 1992-10-05 | 224 | 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