Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PON · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202433 | Aqueduct 200 Cervical Dilation Balloon Catheter | Gtimd, LLC | 2021-10-15 | 416 | 0 |
| K202427 | Aqueduct 100 Plus Cervical Dilation Balloon Catheter | Gtimd, LLC | 2020-11-06 | 73 | 0 |
| K190813 | CrossBay Cervical Dilator Catheter System | Crossbay Medical | 2019-08-23 | 147 | 0 |
| K160664 | Aqueduct 100 Cervical Dilator | Gtimd, LLC | 2016-08-01 | 145 | 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