Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Open Implants, LLC — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250967 | Sherlock | Open Implants, LLC | 2025-06-26 | 87 | 0 |
| K220482 | Sherlock | Open Implants, LLC | 2022-06-21 | 123 | 0 |
| K212664 | Sherlock | Open Implants, LLC | 2021-11-30 | 99 | 0 |
| K193335 | Sherlock | Open Implants, LLC | 2020-03-24 | 113 | 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