# SteriLance Medical (Suzhou), Inc.

- Location (FDA's records): Suzhou, CN
- FDA decisions: 11 (2016–2026): 11 510(k) clearances
- Product codes: QRK (4), FMK (4), QRL (2), FMI (1)
- 510(k) review time since 2016: median 100 days, against 87 for FDA's reviews in the same codes and years (3 of 7 faster)
- Predicates its devices cite: 11 (6 its own); citations of its devices by later devices: 12 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Promisemed Hangzhou Meditech Co., Ltd.: 3 (https://510kreport.com/company/promisemed-hangzhou-meditech)
- Wenzhou Beipu Science & Technology Co., Ltd.: 1 (https://510kreport.com/company/wenzhou-beipu-science-technology)
- ACON Laboratories, Inc.: 1 (https://510kreport.com/company/acon-laboratories)

## Firms that cite its devices most
- Ascensia Diabetes Care U.S., Inc.: 2 (https://510kreport.com/company/ascensia-diabetes-care-us)
- Owen Mumford, Ltd.: 1 (https://510kreport.com/company/owen-mumford)
- Tianjin Huahong Technology Co., Ltd.: 1 (https://510kreport.com/company/tianjin-huahong-technology)
- Ningbo Medsun Medical Co., Ltd.: 1 (https://510kreport.com/company/ningbo-medsun-medical)
- Htl-Strefa S.A: 1 (https://510kreport.com/company/htl-strefa-s-a)

## Its most-cited devices
- K210745: Heel Incision Safety Lancet (2021), cited by 4
- K221507: Disposable Blood Lancet (2022), cited by 4
- K221970: Lancing device (2022), cited by 2
- K244031: Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) (2025), cited by 1
- K221521: Disposable Safety Lancet (2022), cited by 1

## Recent decisions
- K262631: Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) (Aug 25, 2026)
- K260122: Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) (Jul 6, 2026)
- K261634: Disposable Blood Lancet (Soft) (Jun 12, 2026)
- K244031: Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) (Feb 26, 2025)
- K244036: Heel Incision Safety Lancet (SteriHeel 2) (Feb 26, 2025)
- K233796: Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro) (Jan 16, 2024)
- K221521: Disposable Safety Lancet (Oct 28, 2022)
- K221507: Disposable Blood Lancet (Aug 31, 2022)

Source page: https://510kreport.com/company/sterilance-medical-suzhou