Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
GDH · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
19 daysmedian FDA review time
38 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K903419 | MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE | United States Surgical, A Division of Tyco Healthc | 1990-08-09 | 9 | 0 |
| K900487 | MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVE | United States Surgical, A Division of Tyco Healthc | 1990-02-09 | 17 | 0 |
| K891901 | GOUGES, ALEXANDER, BISHOP, LUCAS | Zinnanti Surgical Instruments, Inc. | 1989-04-12 | 19 | 0 |
| K874879 | AUTO SUTURE(R) SURGIPORT DISPOS SURG TROCAR/SLEEVE | United States Surgical, A Division of Tyco Healthc | 1987-12-17 | 38 | 0 |
| K842822 | CHERMEL BONE GOUGES | Cher Mel Corp. | 1984-08-02 | 14 | 0 |
| K760850 | PARKES HUMP GAUGE STRAIGHT 7 (18 CM) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-11-03 | 19 | 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