510(k) Report

Devices descending from K113513

46 later devices reach Plancet through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd.201945—
+2K223314Disposable Blood LancetsHuaian Hening Medical Instruments Co., Ltd.20230—
+2K222055Disposable Sterile LancetTianjin Rilifine Medical Device Co., Ltd.20220—
+2K221521Disposable Safety LancetSteriLance Medical (Suzhou), Inc.20221—
+2K222090Safety LancetNingbo Medsun Medical Co., Ltd.20222—
+2K221383MedtFine Blood LancetShanghai Carelife International Trading Co., Ltd.20220—
+2K221839LancetHebei Xinle Sci&Tech Co., Ltd.20220—
+2K221507Disposable Blood LancetSteriLance Medical (Suzhou), Inc.20225—
+2K220387Disposable Blood LancetsSuzhou Kyuan Medical Apparatus Co., Ltd.20220—
+2K220643DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance…Htl-Strefa S.A20220—
+2K220475Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T…Tianjin Huahong Technology Co., Ltd.20227—
+2K221368Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd.20224—
+2K220370Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)Tianjin Huahong Technology Co., Ltd.202214—
+3K261634Disposable Blood Lancet (Soft)SteriLance Medical (Suzhou), Inc.20260—
+3K261045Verifine Safety LancetsPromisemed Hangzhou Meditech Co., Ltd.20260—
+3K250016droplet® personal lancetsHtl-Strefa S.A20250—
+3K244031Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood…SteriLance Medical (Suzhou), Inc.20251—
+3K243533Sterilized Eol Auto Lancet; Sterilized Eol Lancet PlusHlb Co., Ltd. Healthcare20250—
+3K243306Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing…Tianjin Huahong Technology Co., Ltd.20243—
+3K242627Safety LancetNingbo Medsun Medical Co., Ltd.20240—
+3K242622Sterile Lancets for Single UseNingbo Caremed Medical Products Co., Ltd.20240—
+3K242316Safety LancetNingbo Medsun Medical Co., Ltd.20240—
+3K241848MedtFine Safety LancetNingbo Caremed Medical Products Co., Ltd.20240—
+3K241750Medifun Safety Lancet ( MSL1 series)Medifun Corporation20240—
+3K241810MICROLET®NEXT LancetAscensia Diabetes Care U.S., Inc.20240—
+3K241627Safety Lancet (XXXV)Tianjin Huahong Technology Co., Ltd.20240—
+3K240806Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)Tianjin Huahong Technology Co., Ltd.20243—
+3K233796Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable…SteriLance Medical (Suzhou), Inc.20240—
+3K232330Lancing SystemNingbo Medsun Medical Co., Ltd.20240—
+3K223208Safety LancetSuzhou Zhenwu Medical Co., Ltd.20231—
+3K222408Disposable Safety LancetBeijing Ruicheng Medical Supplies Co., Ltd.20220—
+3K222246Disposable Sterile LancetTianjin Rilifine Medical Device Co., Ltd.20220—
+3K221783SafetiCET Safety LancetNsp Tech Pte, Ltd.20220—
+3K222376Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)Shandong Lianfa Medical Plastic Products Co., Ltd.20220—
+3K221131Tasso+Tasso, Inc.20223—
+4K262631Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)SteriLance Medical (Suzhou), Inc.20260—
+4K262135Lancing deviceTianjin Huahong Technology Co., Ltd.20260—
+4K262211LancetTianjin Huahong Technology Co., Ltd.20260—
+4K260191Safety lancet (XXXVII)Tianjin Huahong Technology Co., Ltd.20261—
+4K253706Lancing device (HH-XV-T)Tianjin Huahong Technology Co., Ltd.20250—
+4K251694safety lancetTianjin Huahong Technology Co., Ltd.20250—
+4K223826NanoDrop LancetDrawbridge Health, Inc.20240—
+4K223201TAP LancetYourbio Health, Inc.20232—
+5K262526Safety lancet (XL)Tianjin Huahong Technology Co., Ltd.20260—
+5K242680LetsGetChecked ImpressPrivapath Diagnostics Ltd (Dba Letsgetchecked)20250—
+5K234081RedDrop ONE (One)Reddrop DX20240—