Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FFA · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K944290 | CATHETERS, BILIARY CATHETERS, UROLOGICAL | Boston Scientific Corp | 1994-12-08 | 97 | 5 |
| K864770 | SUCTION TUBE | New England Surgical Instrument Corp. | 1987-02-24 | 81 | 0 |
| K833061 | C-FLEX PENROSE DRAINAGE TUBE | Concept, Inc. | 1983-11-07 | 59 | 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