Qingdao Kingon Medical Science and Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Qingdao Kingon Medical Science and Technology Co., Ltd.” (first 2020, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 222 days. Since 2017 the median was 222 days, against 224 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 382 |
| 2021 | 0 | — |
| 2022 | 1 | 480 |
| 2023 | 2 | 222 |
| 2024 | 0 | — |
| 2025 | 2 | 184 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Qingdao Kingon Medical Science and Technology Co., Ltd. took a median 222 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 224 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAW | Generator, Oxygen, Portable | 6 | 6 |
Review panels
- Anesthesiology (6)
Most recent Qingdao Kingon Medical Science and Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251764 | Oxygen Concentrator-P2-O5E | CAW | 2025-12-22 | 196 |
| K242718 | Portable Oxygen Concentrator (P2-TOC) | CAW | 2025-02-28 | 171 |
| K230702 | Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3) | CAW | 2023-10-18 | 218 |
| K223379 | Portable Oxygen Concentrator (Model: P2-E7, P2-E) | CAW | 2023-06-22 | 227 |
| K210371 | Portable Oxygen Concentrator, model: P2-E6 | CAW | 2022-06-03 | 480 |
| K190304 | Kingon P2 Oxygen Concentrator | CAW | 2020-02-29 | 382 |
Recalls
openFDA lists no recalls under a recalling firm named Qingdao Kingon Medical Science and Technology Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Qingdao Hisense Medical Equipment Co., Ltd. (9 510(k)s)
- Qingdao Bestex Rubber & Plastic Products Co., Ltd. (6 510(k)s)
- Qingdao Hightop Biotech Co., Ltd. (3 510(k)s)
- Qingdao Bright Moon Biomedical Materials Co., Ltd. (2 510(k)s)
- Qingdao Future Medical Technology Co., Ltd. (2 510(k)s)
- Qingdao Lang Hui Import & Export Co., Ltd. (2 510(k)s)
- Qingdao Yasee Medical Device Co., Ltd. (2 510(k)s)
- Qingdao Youjia Hygiene Technology Co., Ltd. (2 510(k)s)
- Qingdao Hainuo Biological Engineering Co., Ltd. (1 510(k)s)
- Qingdao Kingston Medical Devices, Ltd. (1 510(k)s)
- Qingdao Likangyuan Medical Device Co., Ltd. (1 510(k)s)
- Qingdao Shuang Die Latex Production Co.,Ltd (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Qingdao Kingon Medical Science and Technology Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Qingdao Kingon Medical Science and Technology Co., Ltd.” (first 2020, latest 2025), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Qingdao Kingon Medical Science and Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Qingdao Kingon Medical Science and Technology Co., Ltd. is 222 days. Since 2017: 222 days, versus 224 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Qingdao Kingon Medical Science and Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are CAW (Generator, Oxygen, Portable, 6).
Next steps
- See all 6 Qingdao Kingon Medical Science and Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code CAW, Qingdao Kingon Medical Science and Technology Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.