Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ncontact Surgical, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
237 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142084 | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX | Ncontact Surgical, Inc. | 2014-10-28 | 89 | 0 |
| K120857 | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX | Ncontact Surgical, Inc. | 2012-11-13 | 237 | 0 |
| K090202 | NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK- | Ncontact Surgical, Inc. | 2009-02-17 | 21 | 0 |
| K082203 | NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;C | Ncontact Surgical, Inc. | 2008-12-30 | 147 | 0 |
| K071819 | NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK- | Ncontact Surgical, Inc. | 2007-07-26 | 23 | 0 |
| K063012 | NCONTACT COAGULATION SYSTEM KIT, MODEL CSK | Ncontact Surgical, Inc. | 2006-12-01 | 60 | 0 |
| K062539 | NCONTACT COAGULATION SYSTEM KIT | Ncontact Surgical, Inc. | 2006-12-01 | 94 | 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