Lkc Technologies, Inc.: FDA clearances and approvals
Lkc Technologies, Inc. has 8 FDA 510(k) clearances (first 1976, latest 2015), across 8 product codes in 3 review panels. Median 510(k) review time: 53 days. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 249 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 | 1 |
| GWE | Stimulator, Photic, Evoked Response | 1 | 1 |
| GWF | Stimulator, Electrical, Evoked Response | 1 | 1 |
| HIT | Tester, Color Vision | 1 | 1 |
| HIW | Anomaloscope | 1 | 1 |
| HLX | Photostimulator, Ac-Powered | 1 | 1 |
| HLZ | Electrode, Corneal | 1 | 1 |
| HPT | Perimeter, Automatic, Ac-Powered | 1 | 1 |
Review panels
- Ophthalmic (5)
- Neurology (2)
- Cardiovascular (1)
Most recent Lkc Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142567 | RETeval Visual Electrodiagnostic Device | GWE | 2015-05-19 | 249 |
| K914163 | SCOPTOPIC SENSITIVITY TEST-1[SST-1] | HLX | 1991-10-25 | 38 |
| K913962 | ANOMALOSCOPE QUADRANT TEST-6 | HIW | 1991-10-23 | 48 |
| K875026 | ANOMALOSCOPE PLATE TEST - 5 [APT-5] | HIT | 1988-02-05 | 60 |
| K874336 | PATTERN DISCRIMINATION PERIMETER | HPT | 1988-01-12 | 82 |
| K820414 | UNIVERSAL TESTING & ANALYSIS SYSTEMS | GWF | 1982-03-04 | 20 |
| K790109 | TELEMETRY, BIOMEDICAL | DRG | 1979-03-16 | 58 |
| K760199 | ELECTRORETINOGRAPH | HLZ | 1976-08-04 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Lkc Technologies, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Lkc Technologies, Inc. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03065881: RETeval All Comers Trial (REACT) (Completed, started 2017-02-13)
- NCT02466607: Study of Stimulus Parameters in Flicker Electroretinogram (ERG) (Completed, started 2015-03)
Frequently asked questions
How many FDA 510(k) clearances does Lkc Technologies, Inc. have?
Lkc Technologies, Inc. has 8 FDA 510(k) clearances (first 1976, latest 2015), across 8 product codes in 3 review panels.
How long does FDA take to clear Lkc Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Lkc Technologies, Inc.'s cleared 510(k)s is 53 days.
What devices does Lkc Technologies, Inc. make?
Its most frequent FDA product codes are DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency, 1); GWE (Stimulator, Photic, Evoked Response, 1); GWF (Stimulator, Electrical, Evoked Response, 1).
Has Lkc Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Lkc Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 8 Lkc Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRG, Lkc Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.