FDA applicant
Nsp Tech Pte, Ltd.
FDA records 5 decisions for Nsp Tech Pte, Ltd. (Singapore, SG) from 2019 to 2022: 5 510(k) clearances. Most are in product codes JKA (Tubes, Vials, Systems, Serum Separators, Blood…) and FMK (Single Use Only Blood Lancet With An Integral…). Since 2016 its 510(k)s took a median of 169 days from receipt to decision, against 181 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 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 Nsp Tech Pte, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like Nsp Tech Pte, 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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