Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QRL — Predicate Candidate Screening
26 FDA 510(k) clearances under this product code; the 50 most recent screened below.
91 daysmedian FDA review time
188 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K262211 | Lancet | Tianjin Huahong Technology Co., Ltd. | 2026-07-22 | 22 | 0 |
| K260122 | Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) | SteriLance Medical (Suzhou), Inc. | 2026-07-06 | 172 | 0 |
| K253706 | Lancing device (HH-XV-T) | Tianjin Huahong Technology Co., Ltd. | 2025-12-09 | 15 | 0 |
| K250813 | MICROLET®NEXT 2 Lancing Device | Ascensia Diabetes Care U.S., Inc. | 2025-05-14 | 58 | 0 |
| K243306 | Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI | Tianjin Huahong Technology Co., Ltd. | 2024-11-15 | 25 | 0 |
| K232912 | Facet Aurora Reusable Lancet Base | Facet Technologies, LLC | 2024-01-25 | 128 | 0 |
| K231797 | Medifun Lancing Device, Model No. LD-E1 | Medifun Corporation | 2023-11-22 | 155 | 0 |
| K223643 | Verifine® Ease Lancing Device, Verifine® Lancing Device | Promisemed Hangzhou Meditech Co., Ltd. | 2023-02-21 | 77 | 0 |
| K221419 | TD-5010 Lancing Device and TD-5084 Sterile Lancets | Gostar Co., Ltd. | 2023-01-20 | 249 | 0 |
| K222472 | Lancing System, Sterile Lancet for Single Use, Lancing Devic | Shandong Lianfa Medical Plastic Products Co. , Ltd. | 2022-11-30 | 106 | 1 |
| K223099 | Facet Manatee Reusable Lancing Base | Facet Technologies, LLC | 2022-11-28 | 59 | 0 |
| K222656 | LDE4 Lancing Device | I-Sens, Inc. | 2022-11-23 | 82 | 0 |
| K222246 | Disposable Sterile Lancet | Tianjin Rilifine Medical Device Co., Ltd. | 2022-11-21 | 118 | 0 |
| K222539 | Facet Blood Lancets | Facet Technologies, LLC | 2022-11-18 | 88 | 0 |
| K221072 | TRUEdraw Lancing Device, Mini Lancing Device | Trividia Health | 2022-10-18 | 189 | 0 |
| K221175 | Multi-Lancet Device 2, ReliOn Premier Lancing Device | Arkray, Inc. | 2022-10-17 | 175 | 0 |
| K221613 | Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet L | Owen Mumford, Ltd. | 2022-10-03 | 122 | 0 |
| K221062 | RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose L | Bionime Corporation | 2022-09-26 | 168 | 0 |
| K222034 | RightLance Blood Lancing System | Beijing Ruicheng Medical Supplies Co., Ltd. | 2022-09-07 | 58 | 0 |
| K221970 | Lancing device | SteriLance Medical (Suzhou), Inc. | 2022-08-30 | 56 | 0 |
| K221546 | OneTouch Delica Plus Lancing System | Asahi Polyslider Co., Ltd. | 2022-08-23 | 88 | 0 |
| K220387 | Disposable Blood Lancets | Suzhou Kyuan Medical Apparatus Co., Ltd. | 2022-08-17 | 188 | 0 |
| K220475 | Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII- | Tianjin Huahong Technology Co., Ltd. | 2022-07-06 | 138 | 0 |
| K220633 | MICROLET NEXT lancing device, MICROLET Lancet | Ascensia Diabetes Care U.S., Inc. | 2022-06-03 | 91 | 0 |
| K220608 | Accu-Chek FastClix Blood Lancing System | Roche Diabetes Care, Inc. | 2022-04-29 | 58 | 0 |
| K214022 | Accu-Chek Softclix Blood Lancing System | Roche Diabetes Care, Inc. | 2022-02-17 | 57 | 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