Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Carticept Medical, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
93 daysmedian FDA review time
439 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151255 | Navigator Aesthetic Delivery System | Carticept Medical, Inc. | 2015-12-30 | 232 | 0 |
| K124053 | NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) | Carticept Medical, Inc. | 2013-03-13 | 72 | 0 |
| K122215 | NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) | Carticept Medical, Inc. | 2012-10-26 | 93 | 0 |
| K120830 | NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) | Carticept Medical, Inc. | 2012-04-16 | 28 | 0 |
| K112067 | NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) | Carticept Medical, Inc. | 2011-09-16 | 59 | 0 |
| K101194 | NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010 | Carticept Medical, Inc. | 2011-07-11 | 439 | 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