Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LK Consulting Group USA, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150747 | EzDent-i /E2/Prora View | LK Consulting Group USA, Inc. | 2015-04-02 | 10 | 0 |
| K130694 | JR IMPLANT SYSTEM | LK Consulting Group USA, Inc. | 2014-06-19 | 462 | 0 |
| K132144 | KERATOR | LK Consulting Group USA, Inc. | 2014-03-21 | 253 | 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