Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen RF Tech Co., Ltd. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
123 daysmedian FDA review time
214 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252587 | HD 8Ch Wrist Array | Shenzhen RF Tech Co., Ltd. | 2026-04-14 | 242 | 0 |
| K252876 | GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 1 | Shenzhen RF Tech Co., Ltd. | 2026-04-01 | 203 | 0 |
| K252179 | GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 1 | Shenzhen RF Tech Co., Ltd. | 2026-02-10 | 214 | 0 |
| K231085 | 1.5T HD T/R Knee Array (10-F34127) | Shenzhen RF Tech Co., Ltd. | 2023-08-18 | 123 | 0 |
| K223203 | 1.5T 24E Posterior Array | Shenzhen RF Tech Co., Ltd. | 2023-03-02 | 139 | 0 |
| K223225 | 8ch T/R Knee Coil | Shenzhen RF Tech Co., Ltd. | 2023-02-14 | 119 | 0 |
| K223239 | 8ch Wrist Coil | Shenzhen RF Tech Co., Ltd. | 2022-12-08 | 49 | 0 |
| K200836 | 8ch Flex Suite | Shenzhen RF Tech Co., Ltd. | 2020-07-22 | 113 | 0 |
| K172222 | 8ch Flex Suite | Shenzhen RF Tech Co., Ltd. | 2017-12-08 | 137 | 0 |
| K160932 | 8ch Foot Ankle Coil | Shenzhen RF Tech Co., Ltd. | 2016-08-01 | 119 | 0 |
| K160935 | 8ch Foot Ankle Coil | Shenzhen RF Tech Co., Ltd. | 2016-07-28 | 115 | 0 |
| K151653 | 8ch Foot Ankle Coil | Shenzhen RF Tech Co., Ltd. | 2015-08-07 | 50 | 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