Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NKX — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
91 daysmedian FDA review time
371 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K060648 | REPROCESSED PHACOEMULSIFICATION TIPS | Alliance Medical Corp. | 2007-03-19 | 371 | 0 |
| K050518 | REPROCESSED PHACOEMUISIFICATION TIPS | Alliance Medical, Inc. | 2005-09-23 | 206 | 0 |
| K030179 | MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES | Surgical Instruments Service and Savings, Inc. | 2003-01-24 | 7 | 1 |
| K012698 | VANGUARD REPROCESSED PHACOEMULSIFICATION | Vanguard Medical Concepts, Inc. | 2001-11-09 | 87 | 0 |
| K012579 | REPROCESSED PHACO TIPS | Sterilmed, Inc. | 2001-11-08 | 91 | 1 |
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