Data / Medical devices / China / Sterilance Medical (Suzhou) Inc.
Sterilance Medical (Suzhou) Inc.: FDA-registered device maker in Suzhou Jiangsu, China, 11 510(k) clearances
Sterilance Medical (Suzhou) Inc. is registered with the FDA (registration 3014649053) in Suzhou Jiangsu, China. It lists 8 device types. The FDA files 11 510(k) clearances under its listings, the newest dated August 25, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014649053
- Address
- No.168 PuTuoShan Road New District, Suzhou Jiangsu, China, 215153
- Owner or operator
- Sterilance Medical (Suzhou) Inc. (9070037)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- November 26, 2003
- Registered through
- 2026
- Brand names listed
- Adjustable Depth Safety Lancets, Asurity, Asurity Cartridge, Blade Arm Achilles, Blades, Blueline Heel Incision Safety Lancets, Clix, Disposable Safety Scalpel and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blade, Scalpel | GES | 1 | Manufacturer | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Manufacturer | accessdata.fda.gov |
| Scalpel, One-Piece | GDX | 1 | Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 25, 2026 | K262631 | Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) | QRK | Substantially Equivalent | SteriLance Medical (Suzhou), Inc. | accessdata.fda.gov |
| July 6, 2026 | K260122 | Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) | QRL | Substantially Equivalent | SteriLance Medical (Suzhou), Inc. | accessdata.fda.gov |
| June 12, 2026 | K261634 | Disposable Blood Lancet (Soft) | QRK | Substantially Equivalent | SteriLance Medical (Suzhou), Inc. | accessdata.fda.gov |
| February 26, 2025 | K244036 | Heel Incision Safety Lancet (SteriHeel 2) | FMK | Substantially Equivalent | SteriLance Medical (Suzhou), Inc. | accessdata.fda.gov |
| February 26, 2025 | K244031 | Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) | QRK | Substantially Equivalent | SteriLance Medical (Suzhou), Inc. | accessdata.fda.gov |
| January 16, 2024 | K233796 | Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro) | FMK | Substantially Equivalent | SteriLance Medical (Suzhou), Inc. | accessdata.fda.gov |
| October 28, 2022 | K221521 | Disposable Safety Lancet | FMK | Substantially Equivalent | SteriLance Medical (Suzhou), Inc. | accessdata.fda.gov |
| August 31, 2022 | K221507 | Disposable Blood Lancet | QRK | Substantially Equivalent | SteriLance Medical (Suzhou), Inc. | accessdata.fda.gov |
| August 30, 2022 | K221970 | Lancing device | QRL | Substantially Equivalent | SteriLance Medical (Suzhou), Inc. | accessdata.fda.gov |
| August 26, 2021 | K210745 | Heel Incision Safety Lancet | FMK | Substantially Equivalent | SteriLance Medical (Suzhou), Inc. | accessdata.fda.gov |
| August 29, 2016 | K153706 | Insulin Pen Needle | FMI | Substantially Equivalent | SteriLance Medical (Suzhou), Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Handle, Scalpel
- All makers of Blade, Scalpel
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
Updated August 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.