Shenzhen RF Tech Co., Ltd.: FDA clearances and approvals
Shenzhen RF Tech Co., Ltd. has 12 FDA 510(k) clearances (first 2015, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time: 121 days. Since 2017 its median was 137 days, against 88 days for all cleared 510(k)s in the same product codes.
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, Shenzhen RF Tech Co., Ltd.'s cleared 510(k)s 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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Shenzhen RF Tech Co., Ltd.'s product codes (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)
Frequently asked questions
How many FDA 510(k) clearances does Shenzhen RF Tech Co., Ltd. have?
Shenzhen RF Tech Co., Ltd. has 12 FDA 510(k) clearances (first 2015, latest 2026), across 2 product codes in 1 review panel.
How long does FDA take to clear Shenzhen RF Tech Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Shenzhen RF Tech Co., Ltd.'s cleared 510(k)s is 121 days. Since 2017: 137 days, versus 88 days for all cleared 510(k)s in the same product codes.
What devices does Shenzhen RF Tech Co., Ltd. make?
Its most frequent FDA product codes are MOS (Coil, Magnetic Resonance, Specialty, 11); LNH (System, Nuclear Magnetic Resonance Imaging, 1).
Has Shenzhen RF Tech Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Shenzhen RF Tech Co., Ltd. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.