Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lkc Technologies, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
58 daysmedian FDA review time
249 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142567 | RETeval Visual Electrodiagnostic Device | Lkc Technologies, Inc. | 2015-05-19 | 249 | 0 |
| K914163 | SCOPTOPIC SENSITIVITY TEST-1[SST-1] | Lkc Technologies, Inc. | 1991-10-25 | 38 | 0 |
| K913962 | ANOMALOSCOPE QUADRANT TEST-6 | Lkc Technologies, Inc. | 1991-10-23 | 48 | 0 |
| K875026 | ANOMALOSCOPE PLATE TEST - 5 [APT-5] | Lkc Technologies, Inc. | 1988-02-05 | 60 | 0 |
| K874336 | PATTERN DISCRIMINATION PERIMETER | Lkc Technologies, Inc. | 1988-01-12 | 82 | 0 |
| K820414 | UNIVERSAL TESTING & ANALYSIS SYSTEMS | Lkc Technologies, Inc. | 1982-03-04 | 20 | 0 |
| K790109 | TELEMETRY, BIOMEDICAL | Lkc Technologies, Inc. | 1979-03-16 | 58 | 0 |
| K760199 | ELECTRORETINOGRAPH | Lkc Technologies, Inc. | 1976-08-04 | 28 | 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