FDA applicant
Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.
FDA records 2 decisions for Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. (Shenzhen, CN) from 2019 to 2024: 2 510(k) clearances. All are in product code DTE (Pulse-Generator, Pacemaker, External). Its devices cite 2 predicates, 1 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 Lifetech Cardio Medical Electronics Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like Shenzhen Lifetech Cardio Medical…’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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