Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LZV — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
81 daysmedian FDA review time
347 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021502 | OSCAR, MODEL OE3000 | Orthosonics, Ltd. | 2002-06-06 | 28 | 0 |
| K961101 | STRYKER CEMENT REMOVAL SYSTEM | Stryker Corp. | 1996-07-15 | 118 | 0 |
| K930629 | ACRYL-X II SYSTEM | Sonokinetics, Inc. | 1994-01-21 | 347 | 0 |
| K904156 | ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS | Origin Medsystems, Inc. | 1990-11-27 | 81 | 0 |
| K904180 | PROSTHETIC CEMENT REMOVER | Origin Medsystems, Inc. | 1990-11-20 | 70 | 0 |
| K891472 | IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR | Implant Technology, Inc. | 1989-05-02 | 48 | 0 |
| K890285 | PROSTHETIC CEMENT REMOVER | Albert K. Chin | 1989-04-19 | 90 | 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