Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Qingdao Kingon Medical Science and Technology Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
218 daysmedian FDA review time
480 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251764 | Oxygen Concentrator-P2-O5E | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2025-12-22 | 196 | 0 |
| K242718 | Portable Oxygen Concentrator (P2-TOC) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2025-02-28 | 171 | 0 |
| K230702 | Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2023-10-18 | 218 | 0 |
| K223379 | Portable Oxygen Concentrator (Model: P2-E7, P2-E) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2023-06-22 | 227 | 0 |
| K210371 | Portable Oxygen Concentrator, model: P2-E6 | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2022-06-03 | 480 | 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