Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dornoch Medical Systems, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133786 | DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOC | Dornoch Medical Systems, Inc. | 2014-03-21 | 99 | 0 |
| K123188 | DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DO | Dornoch Medical Systems, Inc. | 2013-03-04 | 144 | 0 |
| K081047 | TRANSPOSAL ULTRA SYSTEMS | Dornoch Medical Systems, Inc. | 2008-04-29 | 15 | 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