Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ChinaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list SteriLance Medical (Suzhou) with 11 510(k) clearances. The most recent is a 510(k) clearance dated Aug 25, 2026: Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 25, 2026 | Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)K262631 · QRK | 510(k) clearances |
| Jul 6, 2026 | Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)K260122 · QRL | 510(k) clearances |
| Jun 12, 2026 | Disposable Blood Lancet (Soft)K261634 · QRK | 510(k) clearances |
| Feb 26, 2025 | Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)K244031 · QRK | 510(k) clearances |
| Feb 26, 2025 | Heel Incision Safety Lancet (SteriHeel 2)K244036 · FMK | 510(k) clearances |
| Jan 16, 2024 | Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)K233796 · FMK | 510(k) clearances |
| Oct 28, 2022 | Disposable Safety LancetK221521 · FMK | 510(k) clearances |
| Aug 31, 2022 | Disposable Blood LancetK221507 · QRK | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
