Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Pango Electronic Co., Ltd. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
195 daysmedian FDA review time
391 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203746 | Venen-trainer (Model: FM150, SFM90) | Shenzhen Pango Electronic Co., Ltd. | 2021-11-10 | 323 | 0 |
| K200716 | Electronic Blood Pressure Monitor | Shenzhen Pango Electronic Co., Ltd. | 2020-12-04 | 261 | 0 |
| K182597 | Infrared thermometer | Shenzhen Pango Electronic Co., Ltd. | 2019-04-03 | 195 | 0 |
| K170151 | Electronic Blood Pressure Monitor | Shenzhen Pango Electronic Co., Ltd. | 2017-10-13 | 269 | 0 |
| K161845 | Electronic Blood Pressure Monitor | Shenzhen Pango Electronic Co., Ltd. | 2017-07-31 | 391 | 0 |
| K131558 | PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, P | Shenzhen Pango Electronic Co., Ltd. | 2013-08-30 | 92 | 0 |
| K131569 | PG-800A SERIES | Shenzhen Pango Electronic Co., Ltd. | 2013-06-14 | 15 | 0 |
| K102988 | ELECTRONIC BLOOD PRESURE MONITOR | Shenzhen Pango Electronic Co., Ltd. | 2010-11-09 | 34 | 0 |
| K102920 | ELECTRONIC BLOOD PRESSURE MONITOR | Shenzhen Pango Electronic Co., Ltd. | 2010-10-15 | 14 | 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