Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LXI · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
427 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K930573 | SYNVASIVE CERAMIC SUTTING BLOCK | Synvasive Technology, Inc. | 1994-04-07 | 427 | 0 |
| K910712 | VILLAN (VIDEO LIFT LINK ANALYSIS) | Physio Systems, Inc. | 1991-05-21 | 90 | 0 |
| K892655 | ACL DRILL GUIDE SYSTEM | Baxter Healthcare Corp | 1989-09-28 | 168 | 0 |
| K890445 | PERSONAL ALERT ASSIST DEVICE | Silent Call Corp. | 1989-05-19 | 112 | 0 |
| K882407 | BOW & ARROW DRILL GUIDE | Instrument Makar, Inc. | 1988-09-06 | 88 | 0 |
| K881378 | PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE | Pfizer, Inc. | 1988-06-17 | 77 | 0 |
| K880739 | DYONICS DRILL GUIDE/ISOMETER SYSTEM | Dyonics, Inc. | 1988-03-21 | 26 | 0 |
| K854254 | TENSION-ISOMETER | Medmetric Corp. | 1985-11-15 | 24 | 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