FDA applicant
Shenzhen Pango Electronic Co., Ltd.
FDA records 9 decisions for Shenzhen Pango Electronic Co., Ltd. (Shenzhen, CN) from 2010 to 2021: 9 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and FLL (Continuous Measurement Thermometer). Since 2016 its 510(k)s took a median of 269 days from receipt to decision, against 184 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 5 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Shenzhen Pango Electronic Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Shenzhen Pango Electronic Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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