Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Confluent Surgical,Inc — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
65 daysmedian FDA review time
102 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091315 | COVIDIEN EXTENDED TIP APPLICATOR | Confluent Surgical,Inc | 2009-06-05 | 32 | 3 |
| K072790 | CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-00 | Confluent Surgical,Inc | 2008-01-11 | 102 | 0 |
| K070814 | MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND | Confluent Surgical,Inc | 2007-05-30 | 65 | 0 |
| K061183 | CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093 | Confluent Surgical,Inc | 2006-06-01 | 34 | 0 |
| K050998 | CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS | Confluent Surgical,Inc | 2005-06-15 | 56 | 0 |
| K042588 | CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093 | Confluent Surgical,Inc | 2004-12-09 | 78 | 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