SteriLance Medical (Suzhou), Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “SteriLance Medical (Suzhou), Inc.” (first 2016, latest 2026), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 58 days. Since 2017 the median was 58 days, against 112 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 250 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 167 |
| 2022 | 3 | 100 |
| 2023 | 0 | — |
| 2024 | 1 | 48 |
| 2025 | 2 | 58 |
| 2026 | 3 | 27 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name SteriLance Medical (Suzhou), Inc. took a median 58 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 4 | 4 |
| QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | 4 | 4 |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
Review panels
Most recent SteriLance Medical (Suzhou), Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262631 | Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) | QRK | 2026-08-25 | 27 |
| K260122 | Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) | QRL | 2026-07-06 | 172 |
| K261634 | Disposable Blood Lancet (Soft) | QRK | 2026-06-12 | 25 |
| K244036 | Heel Incision Safety Lancet (SteriHeel 2) | FMK | 2025-02-26 | 58 |
| K244031 | Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) | QRK | 2025-02-26 | 58 |
| K233796 | Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro) | FMK | 2024-01-16 | 48 |
| K221521 | Disposable Safety Lancet | FMK | 2022-10-28 | 156 |
| K221507 | Disposable Blood Lancet | QRK | 2022-08-31 | 100 |
| K221970 | Lancing device | QRL | 2022-08-30 | 56 |
| K210745 | Heel Incision Safety Lancet | FMK | 2021-08-26 | 167 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named SteriLance Medical (Suzhou), Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under SteriLance Medical (Suzhou), Inc.?
FDA lists 11 510(k) clearances under the applicant name “SteriLance Medical (Suzhou), Inc.” (first 2016, latest 2026), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by SteriLance Medical (Suzhou), Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name SteriLance Medical (Suzhou), Inc. is 58 days. Since 2017: 58 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under SteriLance Medical (Suzhou), Inc.?
The most frequent FDA product codes under this applicant name are FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, 4); QRK (Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature, 4); QRL (Multiple Use Blood Lancet For Single Patient Use Only, 2).
Next steps
- See all 11 SteriLance Medical (Suzhou), Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMK, SteriLance Medical (Suzhou), Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.