Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Demetech Corporation — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
118 daysmedian FDA review time
170 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201479 | DemeMASK | Demetech Corporation | 2020-07-24 | 50 | 0 |
| K191361 | DemeDIOX Barbed Absorbable Surgical Suture | Demetech Corporation | 2019-11-07 | 170 | 0 |
| K190777 | DemeTECH DemeFORCE Nonabsorbable Surgical Suture | Demetech Corporation | 2019-07-31 | 127 | 0 |
| K181578 | DemeTECH PTFE Nonabsorbable Surgical Suture | Demetech Corporation | 2018-10-11 | 118 | 0 |
| K181582 | DemeTECH DemeDIOX absorbable surgical suture | Demetech Corporation | 2018-08-27 | 73 | 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