FDA applicant
Shenzhen Pump Medical System Co., Ltd.
FDA records 7 decisions for Shenzhen Pump Medical System Co., Ltd. (Nanshan District, Shenzhen, CN) from 2013 to 2017: 7 510(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 282 days from receipt to decision, against 144 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 3 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 Pump Medical System Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
Planning a device like Shenzhen Pump Medical System 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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