Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Imdk Medical Technology Co., Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
141 daysmedian FDA review time
318 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252655 | Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, | Shenzhen Imdk Medical Technology Co., Ltd. | 2026-05-11 | 262 | 0 |
| K253133 | Wrist Blood Pressure Monitor (BPM-W1VL) | Shenzhen Imdk Medical Technology Co., Ltd. | 2026-02-13 | 141 | 0 |
| K243118 | Arm Blood Pressure Monitor (model: BPM-A7VL) | Shenzhen Imdk Medical Technology Co., Ltd. | 2024-11-26 | 57 | 0 |
| K233040 | EMS/TENS Massager Device | Shenzhen Imdk Medical Technology Co., Ltd. | 2024-02-12 | 140 | 0 |
| K221979 | Pulse Oximeter (Model C101A2, C101B1, C101A3) | Shenzhen Imdk Medical Technology Co., Ltd. | 2022-10-16 | 103 | 0 |
| K173123 | Pulse Oximeter | Shenzhen Imdk Medical Technology Co., Ltd. | 2018-08-13 | 318 | 0 |
| K180419 | Ultrasonic Doppler (Model YM-2T8) | Shenzhen Imdk Medical Technology Co., Ltd. | 2018-07-19 | 154 | 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