Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FMK — Predicate Candidate Screening
110 FDA 510(k) clearances under this product code; the 50 most recent screened below.
62 daysmedian FDA review time
181 days90th percentile
110clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261045 | Verifine Safety Lancets | Promisemed Hangzhou Meditech Co., Ltd. | 2026-05-01 | 31 | 0 |
| K260191 | Safety lancet (XXXVII) | Tianjin Huahong Technology Co., Ltd. | 2026-03-31 | 68 | 0 |
| K253605 | Safety Heel Lancet | Ningbo Medsun Medical Co., Ltd. | 2026-02-20 | 94 | 0 |
| K252490 | Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) | Tianjin Huahong Technology Co., Ltd. | 2026-02-12 | 188 | 0 |
| K251694 | safety lancet | Tianjin Huahong Technology Co., Ltd. | 2025-06-26 | 24 | 0 |
| K244036 | Heel Incision Safety Lancet (SteriHeel 2) | SteriLance Medical (Suzhou), Inc. | 2025-02-26 | 58 | 0 |
| K242680 | LetsGetChecked Impress | Privapath Diagnostics Ltd (Dba Letsgetchecked) | 2025-01-13 | 129 | 0 |
| K243533 | Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus | Hlb Co., Ltd. Healthcare | 2025-01-13 | 59 | 0 |
| K242664 | gentleheel® Adult Incision Device | Gri-Alleset, Inc. | 2024-11-05 | 62 | 0 |
| K242627 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. | 2024-10-30 | 57 | 0 |
| K242316 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. | 2024-08-28 | 23 | 0 |
| K241848 | MedtFine Safety Lancet | Ningbo Caremed Medical Products Co., Ltd. | 2024-08-20 | 54 | 0 |
| K241750 | Medifun Safety Lancet ( MSL1 series) | Medifun Corporation | 2024-08-15 | 58 | 0 |
| K241627 | Safety Lancet (XXXV) | Tianjin Huahong Technology Co., Ltd. | 2024-06-20 | 14 | 0 |
| K240806 | Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV | Tianjin Huahong Technology Co., Ltd. | 2024-05-21 | 57 | 0 |
| K234081 | RedDrop ONE (One) | Reddrop DX | 2024-03-21 | 90 | 0 |
| K223826 | NanoDrop Lancet | Drawbridge Health, Inc. | 2024-02-22 | 428 | 0 |
| K233796 | Disposable safety lancet (Impress); Disposable safety lancet | SteriLance Medical (Suzhou), Inc. | 2024-01-16 | 48 | 0 |
| K232488 | Accu-Chek Safe-T-Pro Plus Lancing Device | Roche Diabetes Care, Inc. | 2023-11-13 | 88 | 0 |
| K232509 | Accu-Chek Safe-T-Pro Uno Lancing Device | Roche Diabetes Care, Inc. | 2023-11-13 | 87 | 0 |
| K231124 | Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal ( | Owen Mumford, Ltd. | 2023-06-27 | 68 | 0 |
| K223201 | TAP Lancet | Yourbio Health, Inc. | 2023-04-19 | 187 | 0 |
| K223352 | Tenderfoot | Accriva Diagnostics, Inc. | 2023-03-02 | 120 | 0 |
| K223900 | babyLance Safety Heelstick (BLM, BLN, BLP) | Clinical Innovations, LLC | 2023-02-24 | 58 | 0 |
| K223370 | NeatNick Heel Safety Lancet | Facet Technologies, LLC | 2023-02-13 | 101 | 0 |
| K223208 | Safety Lancet | Suzhou Zhenwu Medical Co., Ltd. | 2023-02-10 | 116 | 0 |
| K222801 | Safety Lancet | Sarstedt AG & CO KG | 2023-01-25 | 131 | 0 |
| K223313 | Disposable Safety Lancets | Huaian Hening Medical Instruments Co., Ltd. | 2023-01-23 | 87 | 0 |
| K223243 | BD Microtainer® Contact-Activated Lancets; BD Microtainer® Q | Becton, Dickinson and Company | 2022-12-16 | 57 | 0 |
| K222408 | Disposable Safety Lancet | Beijing Ruicheng Medical Supplies Co., Ltd. | 2022-11-29 | 111 | 0 |
| K222055 | Disposable Sterile Lancet | Tianjin Rilifine Medical Device Co., Ltd. | 2022-11-15 | 126 | 0 |
| K222168 | Unistik TinyTouch Sterile Single-Use Heel Incision Safety La | Owen Mumford, Ltd. | 2022-11-03 | 105 | 0 |
| K222084 | OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance | Asahi Polyslider Co., Ltd. | 2022-11-02 | 110 | 0 |
| K221521 | Disposable Safety Lancet | SteriLance Medical (Suzhou), Inc. | 2022-10-28 | 156 | 0 |
| K222303 | Unistik® Pro | Owen Mumford, Ltd. | 2022-10-25 | 85 | 0 |
| K221783 | SafetiCET Safety Lancet | Nsp Tech Pte, Ltd. | 2022-10-24 | 125 | 0 |
| K221778 | Disposable Safety Lancets | Suzhou Kyuan Medical Apparatus Co., Ltd. | 2022-10-03 | 104 | 0 |
| K222376 | Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and AP | Shandong Lianfa Medical Plastic Products Co. , Ltd. | 2022-10-03 | 59 | 0 |
| K222090 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. | 2022-09-30 | 77 | 0 |
| K222224 | SurgiLance® Safety Lancet | Medipurpose Pte. , Ltd. | 2022-09-22 | 59 | 0 |
| K221839 | Lancet | Hebei Xinle Sci&Tech Co., Ltd. | 2022-09-19 | 87 | 0 |
| K222111 | Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G | Owen Mumford, Ltd. | 2022-09-07 | 51 | 0 |
| K221604 | SafetiHeel, MediHeel, Novaplus | Nsp Tech Pte, Ltd. | 2022-08-22 | 81 | 0 |
| K221126 | Unistik® 3, sterile single-use safety lancets; Unistik® 3 Va | Owen Mumford, Ltd. | 2022-08-12 | 116 | 0 |
| K221131 | Tasso+ | Tasso, Inc. | 2022-08-12 | 116 | 0 |
| K220643 | DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safet | Htl-Strefa S.A | 2022-07-08 | 126 | 0 |
| K221368 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mi | Promisemed Hangzhou Meditech Co., Ltd. | 2022-06-09 | 28 | 0 |
| K221371 | Promisemed Heel Blood Lancet | Promisemed Hangzhou Meditech Co., Ltd. | 2022-06-08 | 27 | 0 |
| K220849 | Accu-Chek Safe-T-Pro Plus Lancing Device | Roche Diabetes Care, Inc. | 2022-05-19 | 57 | 0 |
| K220370 | Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI | Tianjin Huahong Technology Co., Ltd. | 2022-05-19 | 99 | 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