Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Viatom Technology Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
205 daysmedian FDA review time
680 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242876 | Pulse Oximeter ( PO2, PO2A, PO2B) | Shenzhen Viatom Technology Co., Ltd. | 2025-02-28 | 158 | 0 |
| K203812 | Oxyfit Pulse Oximeter | Shenzhen Viatom Technology Co., Ltd. | 2022-11-08 | 680 | 0 |
| K193348 | Blood Pressure Monitor | Shenzhen Viatom Technology Co., Ltd. | 2020-06-25 | 205 | 0 |
| K191088 | Checkme O2 Pulse Oximeter | Shenzhen Viatom Technology Co., Ltd. | 2019-12-02 | 222 | 0 |
| K190207 | Blood Pressure Monitor | Shenzhen Viatom Technology Co., Ltd. | 2019-08-19 | 196 | 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