Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GAO · 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) |
|---|---|---|---|---|---|
| K932513 | LABELING FOR MYO/WIRE II STERNOTOMY SUTURES | Alto Development Corp. | 1994-01-07 | 227 | 0 |
| K872532 | AUTO SUTURE STAINLESS STEEL SUTURES* | United States Surgical, A Division of Tyco Healthc | 1987-08-05 | 40 | 0 |
| K863034 | SHARPOINT STAINLESS STEEL SUTURE | Chathamborough Research Group, Inc. | 1986-09-30 | 50 | 0 |
| K802248 | DISARP ORIGINAL | Unoplast A/S | 1980-09-26 | 10 | 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