Shenzhen RF Tech Co., Ltd.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Shenzhen RF Tech Co., Ltd.” (first 2015, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 121 days. Since 2017 the median was 137 days, against 88 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 |
|---|---|---|
| 2015 | 1 | 50 |
| 2016 | 2 | 117 |
| 2017 | 1 | 137 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 113 |
| 2021 | 0 | — |
| 2022 | 1 | 49 |
| 2023 | 3 | 123 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 3 | 214 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shenzhen RF Tech Co., Ltd. took a median 137 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | 11 | 11 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 | 1 |
Review panels
- Radiology (12)
Most recent Shenzhen RF Tech Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252587 | HD 8Ch Wrist Array | MOS | 2026-04-14 | 242 |
| K252876 | GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only | MOS | 2026-04-01 | 203 |
| K252179 | GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only | MOS | 2026-02-10 | 214 |
| K231085 | 1.5T HD T/R Knee Array (10-F34127) | MOS | 2023-08-18 | 123 |
| K223203 | 1.5T 24E Posterior Array | LNH | 2023-03-02 | 139 |
| K223225 | 8ch T/R Knee Coil | MOS | 2023-02-14 | 119 |
| K223239 | 8ch Wrist Coil | MOS | 2022-12-08 | 49 |
| K200836 | 8ch Flex Suite | MOS | 2020-07-22 | 113 |
| K172222 | 8ch Flex Suite | MOS | 2017-12-08 | 137 |
| K160932 | 8ch Foot Ankle Coil | MOS | 2016-08-01 | 119 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Shenzhen RF Tech 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Shenzhen RF Tech Co., Ltd. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
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 Root Innovation Technology Co., Ltd. (12 510(k)s)
- Shenzhen Creative Industry Co., Ltd. (11 510(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 RF Tech Co., Ltd.?
FDA lists 12 510(k) clearances under the applicant name “Shenzhen RF Tech Co., Ltd.” (first 2015, latest 2026), across 2 product codes 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 Shenzhen RF Tech Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shenzhen RF Tech Co., Ltd. is 121 days. Since 2017: 137 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shenzhen RF Tech Co., Ltd.?
The most frequent FDA product codes under this applicant name are MOS (Coil, Magnetic Resonance, Specialty, 11); LNH (System, Nuclear Magnetic Resonance Imaging, 1).
Next steps
- See all 12 Shenzhen RF Tech Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MOS, Shenzhen RF Tech 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.