Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lima Intl. Corp. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
182 daysmedian FDA review time
672 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K922613 | CL HIP STEM H/A COATED | Lima Intl. Corp. | 1994-04-05 | 672 | 0 |
| K910836 | LIMA COLLARED CL STEM | Lima Intl. Corp. | 1991-06-14 | 107 | 0 |
| K896851 | PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC | Lima Intl. Corp. | 1991-01-01 | 392 | 0 |
| K900051 | MOORE TYPE ENDO PROSTHESIS | Lima Intl. Corp. | 1990-10-03 | 273 | 0 |
| K902621 | SL-SELF LOCKING TOTAL HIP-FEMORAL COMPONENT | Lima Intl. Corp. | 1990-09-11 | 89 | 0 |
| K896850 | LIMA CERAMIC FEMORAL HEAD BIOLOX BY FELDMUEHLE | Lima Intl. Corp. | 1990-06-05 | 182 | 0 |
| K900257 | MULLER TYPE ACETABULAR CUP | Lima Intl. Corp. | 1990-04-18 | 91 | 0 |
| K885146 | CL UNIVERSAL HIP DEVICE | Lima Intl. Corp. | 1989-04-24 | 130 | 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