Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sterne Equipment Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
221 daysmedian FDA review time
303 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003433 | NEURO-TRAIN III (3) | Sterne Equipment Co., Ltd. | 2001-06-15 | 221 | 0 |
| K980158 | MYO-TRAIN V (5) | Sterne Equipment Co., Ltd. | 1998-07-28 | 193 | 0 |
| K972204 | ACU-RAY HF SERIES PORTABLE X-RAY UNIT | Sterne Equipment Co., Ltd. | 1997-10-08 | 118 | 0 |
| K970155 | NEURO-TRAIN II (2) | Sterne Equipment Co., Ltd. | 1997-03-17 | 60 | 0 |
| K931279 | ACU-RAY | Sterne Equipment Co., Ltd. | 1993-11-03 | 240 | 0 |
| K883896 | NEUROTRAIN | Sterne Equipment Co., Ltd. | 1989-07-14 | 303 | 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