Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LZY · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
567 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231448 | TANDEM Hip System | Smith & Nephew, Inc. | 2023-07-19 | 62 | 1 |
| K111145 | ENDO HEAD | Medacta International | 2011-08-16 | 116 | 0 |
| K974442 | PRE-POWDERED NITRILE EXAMINATION GLOVES | P.T. Latexindo Tobaperkasa | 1998-01-05 | 41 | 0 |
| K915528 | BHR BIPOLAR FEMORAL HEAD COMPONENT | Implantology Corp. | 1993-06-29 | 567 | 0 |
| K915548 | IONGUARD TITANIUM MODULAR HEADS | Biomet, Inc. | 1992-03-10 | 90 | 0 |
| K903084 | MODULAR CATHCART FRACTURE SYSTEM | Depuy, Inc. | 1990-10-03 | 83 | 0 |
| K896580 | UNI-POLAR HEAD | Richards Medical Co., Inc. | 1990-02-15 | 90 | 0 |
| K892059 | FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR | Protek, Inc. | 1989-07-19 | 112 | 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