Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
SteriLance Medical (Suzhou), Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
100 daysmedian FDA review time
250 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260122 | Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) | SteriLance Medical (Suzhou), Inc. | 2026-07-06 | 172 | 0 |
| K261634 | Disposable Blood Lancet (Soft) | SteriLance Medical (Suzhou), Inc. | 2026-06-12 | 25 | 0 |
| K244031 | Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet | SteriLance Medical (Suzhou), Inc. | 2025-02-26 | 58 | 0 |
| K244036 | Heel Incision Safety Lancet (SteriHeel 2) | SteriLance Medical (Suzhou), Inc. | 2025-02-26 | 58 | 0 |
| K233796 | Disposable safety lancet (Impress); Disposable safety lancet | SteriLance Medical (Suzhou), Inc. | 2024-01-16 | 48 | 0 |
| K221521 | Disposable Safety Lancet | SteriLance Medical (Suzhou), Inc. | 2022-10-28 | 156 | 0 |
| K221507 | Disposable Blood Lancet | SteriLance Medical (Suzhou), Inc. | 2022-08-31 | 100 | 0 |
| K221970 | Lancing device | SteriLance Medical (Suzhou), Inc. | 2022-08-30 | 56 | 0 |
| K210745 | Heel Incision Safety Lancet | SteriLance Medical (Suzhou), Inc. | 2021-08-26 | 167 | 0 |
| K153706 | Insulin Pen Needle | SteriLance Medical (Suzhou), Inc. | 2016-08-29 | 250 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda