Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JLK, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
101 daysmedian FDA review time
267 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252421 | JLK-NCCT | JLK, Inc. | 2026-03-24 | 235 | 0 |
| K243611 | JLK-SDH | JLK, Inc. | 2025-03-03 | 101 | 0 |
| K250348 | JLK-AILink | JLK, Inc. | 2025-02-25 | 19 | 0 |
| K243363 | JLK-ICH | JLK, Inc. | 2025-01-03 | 66 | 0 |
| K242709 | JLK-PWI | JLK, Inc. | 2024-11-04 | 56 | 0 |
| K242556 | JLK-CTP | JLK, Inc. | 2024-10-16 | 49 | 0 |
| K241480 | JBS-LVO | JLK, Inc. | 2024-09-27 | 126 | 0 |
| K233196 | Medihub Prostate | JLK, Inc. | 2024-06-21 | 267 | 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