FDA 510(k) Applications for Medical Device Product Code "FMK"
(Lancet, Blood)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K223352 | Accriva Diagnostics, Inc. | Tenderfoot | 03/02/2023 |
| K113332 | ACON LABORATORIES, INC. | ON CALL CHOSEN LANCING DEVICE | 04/18/2012 |
| K222084 | Asahi Polyslider Co., Ltd. | OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie | 11/02/2022 |
| K223243 | Becton, Dickinson and Company | BD Microtainer« Contact-Activated Lancets; BD Microtainer« QuikheelÖ Lancets | 12/16/2022 |
| K222408 | Beijing Ruicheng Medical Supplies Co., Ltd. | Disposable Safety Lancet | 11/29/2022 |
| K223900 | Clinical Innovations, LLC | babyLance Safety Heelstick (BLM, BLN, BLP) | 02/24/2023 |
| K223370 | Facet Technologies LLC | NeatNick Heel Safety Lancet | 02/13/2023 |
| K153670 | Genteel, LLC | Genteel Lancing Device | 05/12/2016 |
| K172712 | GRI Medical & Electronic Technology Co, Ltd | gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler | 11/06/2017 |
| K220917 | GRI-Alleset, Inc. | gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler | 05/18/2022 |
| K221839 | Hebei Xinle Sci&Tech Co., Ltd | Lancet | 09/19/2022 |
| K220643 | HTL-Strefa S.A. | DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; | 07/08/2022 |
| K223313 | HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD | Disposable Safety Lancets | 01/23/2023 |
| K001162 | MALI-TECH LTD. | GOLDFINGER DEVICE | 08/09/2000 |
| K130132 | MEDIPURPOSE PTE. LTD. | BABYLANCE HEEL INCISION DEVICE | 02/11/2013 |
| K101417 | MEDIPURPOSE PTE. LTD. | BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200 | 10/19/2010 |
| K101145 | MEDIPURPOSE PTE. LTD. | SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 | 10/21/2010 |
| K222224 | MediPurpose Pte. Ltd. | SurgiLance« Safety Lancet | 09/22/2022 |
| K113513 | MICROPOINT TECHNOLOGIES PTE LTD | PLANCET | 07/13/2012 |
| K222090 | Ningbo Medsun Medical Co., Ltd. | Safety Lancet | 09/30/2022 |
| K221783 | NSP Tech Pte Ltd | SafetiCET (SC-150);SafetiCET (SC-180);SafetiCET (SC-220);SafetiCET (SC-250);SafetiCET (SC-250B) | 10/24/2022 |
| K221604 | NSP Tech Pte Ltd | SafetiHeel, MediHeel, Novaplus | 08/22/2022 |
| K222168 | Owen Mumford Ltd | Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler | 11/03/2022 |
| K222111 | Owen Mumford Ltd | Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G | 09/07/2022 |
| K231124 | Owen Mumford Ltd | Unistik« 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G) | 06/27/2023 |
| K221126 | Owen Mumford Ltd | Unistik« 3, sterile single-use safety lancets; Unistik« 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets | 08/12/2022 |
| K222303 | Owen Mumford Ltd | Unistik« Pro | 10/25/2022 |
| K024170 | PELIKAN TECHNOLOGIES, INC | L1 SYSTEM | 04/14/2003 |
| K041665 | PELIKAN TECHNOLOGIES, INC | L1-PRO SYSTEM | 07/23/2004 |
| K221368 | Promisemed Hangzhou Meditech Co., Ltd. | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet | 06/09/2022 |
| K192666 | Promisemed Hangzhou Meditech Co., Ltd. | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet | 12/02/2019 |
| K193009 | Promisemed Hangzhou Meditech Co., Ltd. | Promisemed Heel Blood Lancet | 12/03/2019 |
| K221371 | Promisemed Hangzhou Meditech Co., Ltd. | Promisemed Heel Blood Lancet | 06/08/2022 |
| K220849 | Roche Diabetes Care, Inc. | Accu-Chek Safe-T-Pro Plus Lancing Device | 05/19/2022 |
| K220364 | Roche Diabetes Care, Inc. | Accu-Chek Safe-T-Pro Uno Lancing Device | 04/05/2022 |
| K222801 | Sarstedt AG & CO KG | Safety Lancet | 01/25/2023 |
| K222376 | Shandong Lianfa Medical Plastic Products Co. Ltd. | Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) | 10/03/2022 |
| K221521 | SteriLance Medical (Suzhou) Inc. | Disposable Safety Lancet | 10/28/2022 |
| K210745 | SteriLance Medical (Suzhou) Inc. | Heel Incision Safety Lancet | 08/26/2021 |
| K221778 | Suzhou Kyuan Medical Apparatus Co., Ltd. | Disposable Safety Lancets | 10/03/2022 |
| K223208 | Suzhou Zhenwu Medical Co., Ltd. | Safety Lancet | 02/10/2023 |
| K221131 | Tasso, Inc. | Tasso+ | 08/12/2022 |
| K220372 | Tianjin Huahong Technology Co., Ltd. | Heel Stick Safety Lancet (HHZ-II, HHZ-III) | 05/17/2022 |
| K220370 | Tianjin Huahong Technology Co., Ltd. | Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) | 05/19/2022 |
| K222055 | Tianjin Rilifine Medical Device Co., Ltd. | Disposable Sterile Lancet | 11/15/2022 |
| K223201 | YourBio Health, Inc. | TAP Lancet | 04/19/2023 |
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