Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Chongqing Sunkingdom Medical Instrument Co., Ltd. · 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) |
|---|---|---|---|---|---|
| K222787 | Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3 | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 2023-01-09 | 116 | 0 |
| K191314 | Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 2019-12-19 | 218 | 0 |
| K182306 | Sunkingdom Slit Lamp | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 2018-11-22 | 90 | 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