Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
QRK — Predicate Candidate Screening
16 FDA 510(k) clearances under this product code; the 50 most recent screened below.
89 daysmedian FDA review time
217 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261634 | Disposable Blood Lancet (Soft) | SteriLance Medical (Suzhou), Inc. | 2026-06-12 | 25 | 0 |
| K250016 | droplet® personal lancets | Htl-Strefa S.A | 2025-07-01 | 179 | 0 |
| K244031 | Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet | SteriLance Medical (Suzhou), Inc. | 2025-02-26 | 58 | 0 |
| K242622 | Sterile Lancets for Single Use | Ningbo Caremed Medical Products Co., Ltd. | 2024-10-28 | 55 | 0 |
| K241810 | MICROLET®NEXT Lancet | Ascensia Diabetes Care U.S., Inc. | 2024-08-15 | 55 | 0 |
| K232330 | Lancing System | Ningbo Medsun Medical Co., Ltd. | 2024-01-04 | 154 | 0 |
| K230712 | SG Lanset I, SG Lancets, Soft Lancets | Sewon Medical Co. | 2023-12-06 | 266 | 0 |
| K230310 | STAT Medical Device Lancing System | Stat Medical Devices | 2023-09-08 | 217 | 0 |
| K230759 | SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro ( | Bosungmeditech Co., Ltd. | 2023-06-13 | 85 | 0 |
| K222617 | EasyTouch Lancing Device | Stat Medical Devices | 2023-03-21 | 203 | 0 |
| K223815 | ONE DROP Lancing Device | Stat Medical Devices | 2023-02-15 | 57 | 0 |
| K223314 | Disposable Blood Lancets | Huaian Hening Medical Instruments Co., Ltd. | 2023-01-25 | 89 | 0 |
| K223480 | Medipoint Blood Lancets | Medipoint Holdings, LLC | 2023-01-13 | 56 | 0 |
| K221383 | MedtFine Blood Lancet | Shanghai Carelife International Trading Co. , Ltd. | 2022-09-21 | 131 | 0 |
| K221507 | Disposable Blood Lancet | SteriLance Medical (Suzhou), Inc. | 2022-08-31 | 100 | 0 |
| K221433 | Facet 28G Universal Lancet | Facet Technologies, LLC | 2022-07-15 | 59 | 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