Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
DOX · 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) |
|---|---|---|---|---|---|
| K014195 | KAYAK HYDROPHILIC GUIDE WIRES | Boston Scientific Corp | 2002-03-19 | 88 | 0 |
| K944226 | MSI PROCEDURE KIT | Msi, Inc. | 1995-06-21 | 295 | 0 |
| K900822 | HYDRO-SIL(TM) COATED GUIDEWIRES | National-Standard Medical Products | 1990-07-17 | 146 | 0 |
| K832030 | HEPARIN COATED STAINLESS STEEL/TEFLON | Argon Medical Corp. | 1983-09-29 | 98 | 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