Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)— 510(k) K260122
Substantially EquivalentSteriLance Medical (Suzhou), Inc.
FDA 510(k) clearance K260122 for Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep), Substantially Equivalent on 2026-07-06. Applicant: SteriLance Medical (Suzhou), Inc.. Device class: 2.
Summary
SteriLance Medical (Suzhou)'s Lancing Device comes in five versions (PressGo, LDE3, LDE3AST, LDE5, and EasyStep), filed under QRL, multiple use blood lancets for single patient use only. The record doesn't say how they differ.
Class II, 21 CFR 878.4850. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
SteriLance filed from Suzhou, China. The decision came 172 calendar days after receipt (January 15 to July 6, 2026).
Clearance details
- Applicant
- SteriLance Medical (Suzhou), Inc.
- Product code
- Product code QRL
- Device class
- Class 2
- Regulation
- 21 CFR 878.4850
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suzhou, CN
Recent devices under product code QRL
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view allAdverse events under product code QRL
product code QRL- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
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