Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LAZ · 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) |
|---|---|---|---|---|---|
| K211667 | Disposable Medical Synthetic Nitrile Examination Gloves (Non | Changzhou Universal Medical Equipment Co., Ltd. | 2021-09-23 | 114 | 0 |
| K851474 | VYGON SPINAL ANESTHESIA TRAY CODE NO. 190 | Vygon Corp. | 1985-05-07 | 22 | 0 |
| K823127 | ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL | Syva Co. | 1982-11-29 | 35 | 0 |
| K811461 | EMIT-AND METHOTREXATE CONTROL | Syva Co. | 1981-06-09 | 14 | 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