510(k) Report

Devices descending from K822209

59 later devices reach Autolancet through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222224SurgiLance® Safety LancetMedipurpose Pte., Ltd.20220—
+1K101145Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300, SLB200, SLB250Medipurpose Pte., Ltd.201058—
+2K223313Disposable Safety LancetsHuaian Hening Medical Instruments Co., Ltd.20230—
+2K222084OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus…Asahi Polyslider Co., Ltd.20220—
+2K222303Unistik® ProOwen Mumford, Ltd.20220—
+2K221778Disposable Safety LancetsSuzhou Kyuan Medical Apparatus Co., Ltd.20220—
+2K222090Safety LancetNingbo Medsun Medical Co., Ltd.20222—
+2K222111Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30GOwen Mumford, Ltd.20220—
+2K221126Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use…Owen Mumford, Ltd.20221—
+2K220849Accu-Chek Safe-T-Pro Plus Lancing DeviceRoche Diabetes Care, Inc.20221—
+2K220364Accu-Chek Safe-T-Pro Uno Lancing DeviceRoche Diabetes Care, Inc.20221—
+2K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd.201945—
+3K242627Safety LancetNingbo Medsun Medical Co., Ltd.20240—
+3K242316Safety LancetNingbo Medsun Medical Co., Ltd.20240—
+3K232509Accu-Chek Safe-T-Pro Uno Lancing DeviceRoche Diabetes Care, Inc.20230—
+3K232488Accu-Chek Safe-T-Pro Plus Lancing DeviceRoche Diabetes Care, Inc.20230—
+3K231124Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle…Owen Mumford, Ltd.20230—
+3K223314Disposable Blood LancetsHuaian Hening Medical Instruments Co., Ltd.20230—
+3K222055Disposable Sterile LancetTianjin Rilifine Medical Device Co., Ltd.20220—
+3K221521Disposable Safety LancetSteriLance Medical (Suzhou), Inc.20221—
+3K221383MedtFine Blood LancetShanghai Carelife International Trading Co., Ltd.20220—
+3K221839LancetHebei Xinle Sci&Tech Co., Ltd.20220—
+3K221507Disposable Blood LancetSteriLance Medical (Suzhou), Inc.20225—
+3K220387Disposable Blood LancetsSuzhou Kyuan Medical Apparatus Co., Ltd.20220—
+3K220643DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance…Htl-Strefa S.A20220—
+3K220475Lancet (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—
+3K221368Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd.20224—
+3K220370Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)Tianjin Huahong Technology Co., Ltd.202214—
+4K261634Disposable Blood Lancet (Soft)SteriLance Medical (Suzhou), Inc.20260—
+4K261045Verifine Safety LancetsPromisemed Hangzhou Meditech Co., Ltd.20260—
+4K250016droplet® personal lancetsHtl-Strefa S.A20250—
+4K244031Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood…SteriLance Medical (Suzhou), Inc.20251—
+4K243533Sterilized Eol Auto Lancet; Sterilized Eol Lancet PlusHlb Co., Ltd. Healthcare20250—
+4K243306Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing…Tianjin Huahong Technology Co., Ltd.20243—
+4K242622Sterile Lancets for Single UseNingbo Caremed Medical Products Co., Ltd.20240—
+4K241848MedtFine Safety LancetNingbo Caremed Medical Products Co., Ltd.20240—
+4K241750Medifun Safety Lancet ( MSL1 series)Medifun Corporation20240—
+4K241810MICROLET®NEXT LancetAscensia Diabetes Care U.S., Inc.20240—
+4K241627Safety Lancet (XXXV)Tianjin Huahong Technology Co., Ltd.20240—
+4K240806Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)Tianjin Huahong Technology Co., Ltd.20243—
+4K233796Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable…SteriLance Medical (Suzhou), Inc.20240—
+4K232330Lancing SystemNingbo Medsun Medical Co., Ltd.20240—
+4K223208Safety LancetSuzhou Zhenwu Medical Co., Ltd.20231—
+4K222408Disposable Safety LancetBeijing Ruicheng Medical Supplies Co., Ltd.20220—
+4K222246Disposable Sterile LancetTianjin Rilifine Medical Device Co., Ltd.20220—
+4K221783SafetiCET Safety LancetNsp Tech Pte, Ltd.20220—
+4K222376Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)Shandong Lianfa Medical Plastic Products Co., Ltd.20220—
+4K221131Tasso+Tasso, Inc.20223—
+5K262631Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)SteriLance Medical (Suzhou), Inc.20260—
+5K262135Lancing deviceTianjin Huahong Technology Co., Ltd.20260—
+5K262211LancetTianjin Huahong Technology Co., Ltd.20260—
+5K260191Safety lancet (XXXVII)Tianjin Huahong Technology Co., Ltd.20261—
+5K253706Lancing device (HH-XV-T)Tianjin Huahong Technology Co., Ltd.20250—
+5K251694safety lancetTianjin Huahong Technology Co., Ltd.20250—
+5K223826NanoDrop LancetDrawbridge Health, Inc.20240—
+5K223201TAP LancetYourbio Health, Inc.20232—
+6K262526Safety lancet (XL)Tianjin Huahong Technology Co., Ltd.20260—
+6K242680LetsGetChecked ImpressPrivapath Diagnostics Ltd (Dba Letsgetchecked)20250—
+6K234081RedDrop ONE (One)Reddrop DX20240—