Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Skylark Device & Systems Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
225 daysmedian FDA review time
330 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K053007 | SKYLARK URO PROBE | Skylark Device & Systems Co., Ltd. | 2005-12-05 | 40 | 0 |
| K050174 | BIO-STIM KIT | Skylark Device & Systems Co., Ltd. | 2005-09-07 | 225 | 0 |
| K043306 | SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD- | Skylark Device & Systems Co., Ltd. | 2005-06-06 | 187 | 0 |
| K034005 | SDS-4I | Skylark Device & Systems Co., Ltd. | 2004-11-18 | 330 | 0 |
| K002832 | CONDUCTIVE GEL FOR ULTRASOUND | Skylark Device & Systems Co., Ltd. | 2001-08-06 | 329 | 0 |
| K992652 | SD-730 IF-SDS, PERFECT PULSE IF-SDS | Skylark Device & Systems Co., Ltd. | 2000-02-03 | 181 | 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