FDA applicant
SteriLance Medical (Suzhou), Inc.
FDA records 11 decisions for SteriLance Medical (Suzhou), Inc. (Suzhou, CN) from 2016 to 2026: 11 510(k) clearances. Most are in product codes QRK (Single Use Only Blood Lancet Without An…) and FMK (Single Use Only Blood Lancet With An Integral…). Since 2016 its 510(k)s took a median of 100 days from receipt to decision, against 87 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 6 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 SteriLance Medical (Suzhou), Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like SteriLance Medical (Suzhou), Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report