Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Synectics Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
183 daysmedian FDA review time
223 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K963330 | URODYNAMIC ANALYSIS MODULE | Synectics Medical, Inc. | 1997-04-03 | 223 | 0 |
| K961070 | ESOPHAGEAL MANOMETRY ANALYSIS MODULE | Synectics Medical, Inc. | 1996-06-11 | 85 | 0 |
| K951442 | FLOLAB | Synectics Medical, Inc. | 1995-08-24 | 148 | 0 |
| K946322 | POLYGRAM SOFTWARE | Synectics Medical, Inc. | 1995-07-07 | 191 | 0 |
| K942445 | SYNERGY II | Synectics Medical, Inc. | 1994-11-22 | 183 | 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