Shenzhen Creative Industry Co., Ltd.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Shenzhen Creative Industry Co., Ltd.” (first 2007, latest 2021), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 218 days. Since 2017 the median was 242 days, against 210 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 |
|---|---|---|
| 2012 | 1 | 290 |
| 2013 | 1 | 301 |
| 2014 | 0 | — |
| 2015 | 1 | 138 |
| 2016 | 0 | — |
| 2017 | 1 | 247 |
| 2018 | 1 | 424 |
| 2019 | 1 | 125 |
| 2020 | 0 | — |
| 2021 | 1 | 237 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shenzhen Creative Industry Co., Ltd. took a median 242 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 210 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQA | Oximeter | 7 | 7 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 | 2 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| KNG | Monitor, Ultrasonic, Fetal | 1 | 1 |
Review panels
Most recent Shenzhen Creative Industry Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201468 | Pulse Oximeter | DQA | 2021-01-25 | 237 |
| K192343 | Patient Monitor | DQA | 2019-12-31 | 125 |
| K172792 | Handheld Pulse Oximeter, Model SP-20 | DQA | 2018-11-13 | 424 |
| K170047 | All-in-One Health Monitor, PC-303 | MWI | 2017-09-09 | 247 |
| K150093 | Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1 | DQA | 2015-06-03 | 138 |
| K123711 | PATIENT MONITOR | MWI | 2013-10-01 | 301 |
| K120502 | PC-60NW FINGERTIP OXIMETER | DQA | 2012-12-07 | 290 |
| K093016 | VITAL SIGNS MONITOR | DQA | 2010-03-30 | 182 |
| K082055 | MODEL PC-860 FETAL DOPPLER | KNG | 2009-02-06 | 200 |
| K073152 | PC-180 / PRINCE 180 EASY ECG MONITOR | DSH | 2008-01-10 | 63 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Shenzhen Creative Industry 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.
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (160 510(k)s)
- Shenzhen Dongdixin Technology Co., Ltd. (26 510(k)s)
- Shenzhen Kaiyan Medical Equipment Co., Ltd. (24 510(k)s)
- Shenzhen TPH Technology Co., Ltd. (24 510(k)s)
- Shenzhen Ulike Smart Electronics Co., Ltd. (23 510(k)s)
- Shenzhen AOJ Medical Technology Co., Ltd. (17 510(k)s)
- Shenzhen Beacon Display Technology Co., Ltd. (17 510(k)s)
- Shenzhen Med-Link Electronics Tech Co., Ltd. (14 510(k)s)
- Shenzhen RF Tech Co., Ltd. (12 510(k)s)
- Shenzhen Root Innovation Technology Co., Ltd. (12 510(k)s)
- Shenzhen Jumper Medical Equipment Co., Ltd. (10 510(k)s)
- Shenzhen Kentro Medical Electronics Co., Ltd. (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shenzhen Creative Industry Co., Ltd.?
FDA lists 11 510(k) clearances under the applicant name “Shenzhen Creative Industry Co., Ltd.” (first 2007, latest 2021), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Shenzhen Creative Industry Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shenzhen Creative Industry Co., Ltd. is 218 days. Since 2017: 242 days, versus 210 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shenzhen Creative Industry Co., Ltd.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 7); MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 2); DSH (Recorder, Magnetic Tape, Medical, 1).
Next steps
- See all 11 Shenzhen Creative Industry Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Shenzhen Creative Industry 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.