| Verifine Safety Lancets (K261045) | Promisemed Hangzhou Meditech Co., Ltd. | 2026-05-01 |
| Safety lancet (XXXVII) (K260191) | Tianjin Huahong Technology Co., Ltd. | 2026-03-31 |
| Safety Heel Lancet (K253605) | Ningbo Medsun Medical Co., Ltd. | 2026-02-20 |
| Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) (K252490) | Tianjin Huahong Technology Co., Ltd. | 2026-02-12 |
| safety lancet (K251694) | Tianjin Huahong Technology Co., Ltd. | 2025-06-26 |
| Heel Incision Safety Lancet (SteriHeel 2) (K244036) | SteriLance Medical (Suzhou), Inc. | 2025-02-26 |
| LetsGetChecked Impress (K242680) | Privapath Diagnostics Ltd (Dba Letsgetchecked) | 2025-01-13 |
| Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus (K243533) | Hlb Co., Ltd. Healthcare | 2025-01-13 |
| gentleheel® Adult Incision Device (K242664) | Gri-Alleset, Inc. | 2024-11-05 |
| Safety Lancet (K242627) | Ningbo Medsun Medical Co., Ltd. | 2024-10-30 |
| Safety Lancet (K242316) | Ningbo Medsun Medical Co., Ltd. | 2024-08-28 |
| MedtFine Safety Lancet (K241848) | Ningbo Caremed Medical Products Co., Ltd. | 2024-08-20 |
| Medifun Safety Lancet ( MSL1 series) (K241750) | Medifun Corporation | 2024-08-15 |
| Safety Lancet (XXXV) (K241627) | Tianjin Huahong Technology Co., Ltd. | 2024-06-20 |
| Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.) (K240806) | Tianjin Huahong Technology Co., Ltd. | 2024-05-21 |
| RedDrop ONE (One) (K234081) | Reddrop DX | 2024-03-21 |
| NanoDrop Lancet (K223826) | Drawbridge Health, Inc. | 2024-02-22 |
| Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro) (K233796) | SteriLance Medical (Suzhou), Inc. | 2024-01-16 |
| Accu-Chek Safe-T-Pro Plus Lancing Device (K232488) | Roche Diabetes Care, Inc. | 2023-11-13 |
| Accu-Chek Safe-T-Pro Uno Lancing Device (K232509) | Roche Diabetes Care, Inc. | 2023-11-13 |
| Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G) (K231124) | Owen Mumford, Ltd. | 2023-06-27 |
| TAP Lancet (K223201) | Yourbio Health, Inc. | 2023-04-19 |
| Tenderfoot (K223352) | Accriva Diagnostics, Inc. | 2023-03-02 |
| babyLance Safety Heelstick (BLM, BLN, BLP) (K223900) | Clinical Innovations, LLC | 2023-02-24 |
| NeatNick Heel Safety Lancet (K223370) | Facet Technologies, LLC | 2023-02-13 |
| Safety Lancet (K223208) | Suzhou Zhenwu Medical Co., Ltd. | 2023-02-10 |
| Safety Lancet (K222801) | Sarstedt AG & CO KG | 2023-01-25 |
| Disposable Safety Lancets (K223313) | Huaian Hening Medical Instruments Co., Ltd. | 2023-01-23 |
| BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ Lancets (K223243) | Becton, Dickinson and Company | 2022-12-16 |
| Disposable Safety Lancet (K222408) | Beijing Ruicheng Medical Supplies Co., Ltd. | 2022-11-29 |
| Disposable Sterile Lancet (K222055) | Tianjin Rilifine Medical Device Co., Ltd. | 2022-11-15 |
| 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 (K222168) | Owen Mumford, Ltd. | 2022-11-03 |
| OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie (K222084) | Asahi Polyslider Co., Ltd. | 2022-11-02 |
| Disposable Safety Lancet (K221521) | SteriLance Medical (Suzhou), Inc. | 2022-10-28 |
| Unistik® Pro (K222303) | Owen Mumford, Ltd. | 2022-10-25 |
| SafetiCET Safety Lancet (K221783) | Nsp Tech Pte, Ltd. | 2022-10-24 |
| Disposable Safety Lancets (K221778) | Suzhou Kyuan Medical Apparatus Co., Ltd. | 2022-10-03 |
| Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) (K222376) | Shandong Lianfa Medical Plastic Products Co. , Ltd. | 2022-10-03 |
| Safety Lancet (K222090) | Ningbo Medsun Medical Co., Ltd. | 2022-09-30 |
| SurgiLance® Safety Lancet (K222224) | Medipurpose Pte. , Ltd. | 2022-09-22 |
| Lancet (K221839) | Hebei Xinle Sci&Tech Co., Ltd. | 2022-09-19 |
| Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G (K222111) | Owen Mumford, Ltd. | 2022-09-07 |
| SafetiHeel, MediHeel, Novaplus (K221604) | Nsp Tech Pte, Ltd. | 2022-08-22 |
| Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets (K221126) | Owen Mumford, Ltd. | 2022-08-12 |
| Tasso+ (K221131) | Tasso, Inc. | 2022-08-12 |
| 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; DropSafe Haemolance Plus Safety Lancets (K220643) | Htl-Strefa S.A | 2022-07-08 |
| Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet (K221368) | Promisemed Hangzhou Meditech Co., Ltd. | 2022-06-09 |
| Promisemed Heel Blood Lancet (K221371) | Promisemed Hangzhou Meditech Co., Ltd. | 2022-06-08 |
| Accu-Chek Safe-T-Pro Plus Lancing Device (K220849) | Roche Diabetes Care, Inc. | 2022-05-19 |
| Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) (K220370) | Tianjin Huahong Technology Co., Ltd. | 2022-05-19 |
| gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler (K220917) | Gri-Alleset, Inc. | 2022-05-18 |
| Heel Stick Safety Lancet (HHZ-II, HHZ-III) (K220372) | Tianjin Huahong Technology Co., Ltd. | 2022-05-17 |
| Accu-Chek Safe-T-Pro Uno Lancing Device (K220364) | Roche Diabetes Care, Inc. | 2022-04-05 |
| Heel Incision Safety Lancet (K210745) | SteriLance Medical (Suzhou), Inc. | 2021-08-26 |
| Promisemed Heel Blood Lancet (K193009) | Promisemed Hangzhou Meditech Co., Ltd. | 2019-12-03 |
| Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet (K192666) | Promisemed Hangzhou Meditech Co., Ltd. | 2019-12-02 |
| gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler (K172712) | Gri Medical & Electronic Technology Co., Ltd. | 2017-11-06 |
| Genteel Lancing Device (K153670) | Genteel, LLC | 2016-05-12 |
| BABYLANCE HEEL INCISION DEVICE (K130132) | Medipurpose Pte. , Ltd. | 2013-02-11 |
| PLANCET (K113513) | Micropoint Technologies Pte, Ltd. | 2012-07-13 |
| ON CALL CHOSEN LANCING DEVICE (K113332) | ACON Laboratories, Inc. | 2012-04-18 |
| SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 (K101145) | Medipurpose Pte. , Ltd. | 2010-10-21 |
| BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200 (K101417) | Medipurpose Pte. , Ltd. | 2010-10-19 |
| L1-PRO SYSTEM (K041665) | Pelikan Technologies, Inc. | 2004-07-23 |
| L1 SYSTEM (K024170) | Pelikan Technologies, Inc. | 2003-04-14 |
| GOLDFINGER DEVICE (K001162) | Mali-Tech , Ltd. | 2000-08-09 |
| FREE-LANCE (K944948) | F.F.F. Enterprises, Inc. | 1994-11-17 |
| JENNINGS JAVELIN (K942548) | Jfi Endineering, Inc. | 1994-11-03 |
| FEATHER-TOUCH SINGLE-STICK DEVICE (K942620) | Ulster Scientific, Inc. | 1994-06-22 |
| SOFTTOUCH II LANCET DEVICE (K931258) | Boehringer Mannheim Corp. | 1994-02-10 |
| BABISTICK (K933365) | Graphic Controls Corp. | 1993-10-19 |
| CARELET SAFETY LANCET (K931828) | Gainor Medical Europe, Ltd. | 1993-10-15 |
| MINI-LANCET (K931481) | Pacific Rim Products, Inc. | 1993-10-01 |
| MONOJECT(R) MONOLETTOR SAFETY LANCET (K932785) | Sherwood Medical Co. | 1993-09-29 |
| CLEANLET, CLEANLET XL & KIDS (K931827) | Gainor Medical Europe, Ltd. | 1993-09-13 |
| B-D ULTRA FINE(R) LANCET (K932725) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993-07-23 |
| TENDERLETT FINGER (K923302) | International Technidyne Corp. | 1993-01-22 |
| UNISTIK (K920562) | Ulster Scientific, Inc. | 1992-03-27 |
| TENDERFOOT(R), MODIFICATION (K911997) | International Technidyne Corp. | 1991-07-17 |
| GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD (K902430) | Heraeus Kulzer, Inc. | 1990-08-02 |
| SURELITE AND SURELITE XL BLOOD LANCET (K902416) | Gainor Medical Europe, Ltd. | 1990-08-01 |
| DISPOSABLE IV INDUCTION COVER (K894427) | Central Plastic, Inc. | 1989-09-11 |
| THE AUTOLET LITE (K894474) | Ulster Scientific, Inc. | 1989-08-18 |
| GENNY DENNY IV SHIELD (K885342) | Mercury Enterprises, Inc. | 1989-03-30 |
| TENDERFOOT (K883968) | International Technidyne Corp. | 1988-12-01 |
| ARTERIAL ANCHOR BANDAGE (K883957) | Guidelines, Inc. | 1988-10-18 |
| LANCET, BLOOD (K883420) | Primrose Medical, Inc. | 1988-08-26 |
| MEDI-LET (K880869) | Medicore, Inc. | 1988-03-21 |
| BLOOD LANCET (K850100) | Gainor Medical | 1987-01-29 |
| AMG + MED LANCET (K870017) | Can-Am Surgical Corp. | 1987-01-21 |
| BLOOD LANCET (K865016) | Falcon Medical Industries, Inc. | 1987-01-12 |
| PALS (K863621) | West Lake Marketing | 1986-10-06 |
| DIALET LANCING DEVICE (K861265) | Home Diagnostics, Inc. | 1986-04-30 |
| NEONATAL UNILET (K861243) | Ulster Scientific, Inc. | 1986-04-29 |
| SUEL BLOOD LANCET (K861151) | Exel Intl. | 1986-04-15 |
| GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD (K855203) | Miles Laboratories, Inc. | 1986-02-11 |
| CHURCHHILL LANCET (K854760) | Churchill Corp. | 1986-01-03 |
| ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED (K850150) | Gainor Medical | 1985-02-21 |
| STERILE BLOOD LANCETS (K841677) | Abco Dealers, Inc. | 1984-06-11 |
| HEMASTICK 1-1.5 & 2-DISPOS. BLOOD (K833816) | Medprobe Laboratories | 1983-12-22 |