Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Domain Surgical, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
142 daysmedian FDA review time
302 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142229 | Laparoscopic FMsealer | Domain Surgical, Inc. | 2015-01-02 | 142 | 0 |
| K141484 | OPEN FMSEALER | Domain Surgical, Inc. | 2014-07-30 | 55 | 1 |
| K140384 | FMWAND HANDPIECE SE | Domain Surgical, Inc. | 2014-05-23 | 98 | 0 |
| K130606 | FMWAND FERROMAGNETIC SURGICAL SYSTEM | Domain Surgical, Inc. | 2014-01-03 | 302 | 0 |
| K121881 | DOMAIN SURGICAL SYSTEM | Domain Surgical, Inc. | 2012-10-18 | 114 | 0 |
| K110439 | DOMAIN SURGICAL SYSTEM | Domain Surgical, Inc. | 2011-07-18 | 153 | 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