Devices descending from K904198
86 later devices reach Safety Needle Sheath through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K013006 | Ovus Capless Safety Needle | Ovus Systems | 2002 | 0 | — |
| +1 | K923127 | Needle-Pro Cartridge | Concord/Portex | 1993 | 84 | 1 |
| +2 | K041399 | Hypodermic Needle-Pro Edge Needle Protection Device | Smiths Medical Asd, Inc. | 2004 | 11 | 4 |
| +2 | K031453 | Terumo Surguard 2 Safety Needle | Terumo Medical Corp. | 2003 | 74 | — |
| +2 | K011925 | Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic Needle-Pro… | Sims Portex, Inc. | 2001 | 5 | 1 |
| +3 | K071785 | Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge Safety Device with… | Smiths Medical Asd, Inc. | 2007 | 7 | — |
| +3 | K063450 | Portex Hypodermic Needle- Pro Edge Safety Device, 18GX1, 401810, 19GX1, 401910… | Smiths Medical Asd, Inc. | 2007 | 8 | — |
| +3 | K061194 | Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210, 432510, 432558 | Smiths Medical Asd, Inc. | 2006 | 9 | — |
| +3 | K051865 | Terumo Surguard 2 Safety Needle or Similar | Terumo Medical Corp. | 2005 | 65 | — |
| +3 | K040531 | Terumo SURGUARD2 Safety Needle | Terumo Medical Corp. | 2004 | 67 | — |
| +3 | K024249 | Terumo Surguard Safety Syringe | Terumo Medical Corp. | 2003 | 3 | — |
| +3 | K014073 | Hypodermic Needle-Pro Insulin Syrine & Needle with Needle Protection Device | Portex, Inc. | 2002 | 0 | — |
| +4 | K211634 | Hypodermic Needle-Pro EDGE Safety Device | Smiths Medical Asd, Inc. | 2021 | 5 | — |
| +4 | K190183 | Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2019 | 1 | — |
| +4 | K113422 | Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with Safety Needle | Terumo (Philippines) Corporation | 2012 | 60 | — |
| +4 | K110527 | K-Pack Surshield Needle, Hypodermic Needle for Single Use | Terumo Europe N.V. | 2011 | 3 | — |
| +4 | K082908 | Novaguard, Model 3611001 | West Pharmaceutical Services, Inc. | 2009 | 0 | — |
| +4 | K073188 | Hypodermic Needle-Pro Edge Safety Device | Smiths Medical Asd, Inc. | 2008 | 0 | — |
| +4 | K073206 | Needle-Trap/Needle Safety Label | Schreiner Medipharm | 2008 | 0 | — |
| +4 | K072482 | Hypodermic Needle-Pro Safety Allergy Tray | Smiths Medical Asd, Inc. | 2007 | 0 | — |
| +4 | K063755 | Portex Hypodermic Needle-Pro Fixed Needle Syringe | Smiths Medical Asd, Inc. | 2007 | 2 | Class I |
| +5 | K252098 | PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) | Methyl Co., Ltd. | 2026 | 0 | — |
| +5 | K232943 | Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe | Smiths Medical Asd, Inc. | 2024 | 4 | — |
| +5 | K212095 | SurGuard3 Safety Hypodermic Needle | Terumo Europe N.V. | 2022 | 1 | — |
| +5 | K211555 | Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2021 | 0 | — |
| +5 | K180417 | Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single… | Berpu Medical Technology Co., Ltd. | 2018 | 12 | — |
| +5 | K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle… | Yangzhou Medline Industry, Co., Ltd. | 2017 | 32 | — |
| +5 | K142765 | TM Safety Needle | Thinkmed Medical Technology Co., Ltd. | 2015 | 4 | — |
| +5 | K130212 | Safety Hypodermic Needles with/Without Syringe | Wuxi Yushou Medical Applicances Co., Ltd. | 2013 | 0 | — |
| +5 | K122249 | Terumo SURGUARD3 Safety Needle & Hypodermic Syringe with Safety Needle | Terumo (Philippines) Corporation | 2012 | 4 | — |
| +5 | K111797 | 27 G X 1/2 K-Pack Surshield Needle | Terumo Europe N.V. | 2011 | 2 | — |
| +5 | K093176 | Med-Lok | Sta-Med, LLC | 2010 | 0 | — |
| +6 | K260514 | Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead… | CMT Health PTE., Ltd. | 2026 | 0 | — |
| +6 | K251447 | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) | Terumo Europe N.V. | 2025 | 0 | — |
| +6 | K243309 | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | Terumo Europe N.V. | 2025 | 0 | — |
| +6 | K242291 | SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead… | Sol-Millennium Medical, Inc. | 2024 | 2 | — |
| +6 | K232165 | Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single… | Berpu Medical Technology Co., Ltd. | 2024 | 0 | — |
| +6 | K233037 | Sterile Hypodermic Needles for Single Use | Zhejiang Kindly Medical Device Co., Ltd. | 2023 | 0 | — |
| +6 | K231720 | Sterile Hypodermic Needles for Single Use | Wepon Medical Technology Co., Ltd. | 2023 | 0 | — |
| +6 | K223353 | DropSafeTM SicuraTM | Pikdare Spa | 2022 | 0 | — |
| +6 | K221247 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle… | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2022 | 3 | — |
| +6 | K221079 | Sterile Hypodermic Syringes for Single Use | Sichuan Prius Biotechnology Co., Ltd. | 2022 | 1 | — |
| +6 | K221066 | Sterile Hypodermic Needles for Single Use | Sichuan Prius Biotechnology Co., Ltd. | 2022 | 0 | — |
| +6 | K221080 | Sterile Safety Hypodermic Needles for Single Use | Sichuan Prius Biotechnology Co., Ltd. | 2022 | 0 | — |
| +6 | K212920 | Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for… | Shandong Weigao Group Medical Polymer Co., Ltd. | 2022 | 1 | — |
| +6 | K211214 | Sterile Hypodermic Needles for Single Use | Azur Medical Company, Inc. | 2021 | 4 | — |
| +6 | K210232 | Sterile Hypodermic Needles for Single Use | Zhejiang Kangkang Medical-Devices Co., Ltd. | 2021 | 0 | — |
| +6 | K192551 | 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety… | Jiangsu Caina Medical Co.,Ltd | 2020 | 14 | — |
| +6 | K191644 | TK Safety Needle | Anhui Tiankang Medical Technology Co., Ltd. | 2020 | 3 | — |
| +6 | K193526 | Syringe with safety needle, Safety needle | Jiangsu Caina Medical Co.,Ltd | 2020 | 7 | — |
| +6 | K192679 | Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use… | Gemtier Medical (Shanghai), Inc. | 2020 | 1 | — |
| +6 | K183665 | Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe… | Jiangsu Micsafe Medical Technology Co., Ltd. | 2019 | 0 | — |
| +6 | K152362 | Terumo SurGuard 3 Safety Hypodermic Needle | Terumo (Philippines) Corporation | 2015 | 1 | — |
| +7 | K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R… | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2026 | 0 | — |
| +7 | K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. | 2026 | 0 | — |
| +7 | K252814 | Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead… | CMT Health PTE., Ltd. | 2026 | 0 | — |
| +7 | K252631 | Profoject™ Disposable Needle | CMT Health PTE., Ltd. | 2025 | 0 | — |
| +7 | K242099 | Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle | Sol-Millennium Medical, Inc. | 2024 | 0 | — |
| +7 | K241821 | Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer… | Sol-Millennium Medical, Inc. | 2024 | 2 | — |
| +7 | K231519 | Revital Cady | Revital Healthcare (Epz) Limited | 2023 | 0 | — |
| +7 | K231723 | Sterile Safety Hypodermic Needles for Single Use | Wepon Medical Technology Co., Ltd. | 2023 | 0 | — |
| +7 | K213010 | FEELject LDV (Low dead volume) syringe | Feeltech Co., Ltd. | 2023 | 2 | — |
| +7 | K223334 | Sterile Hypodermic Needles for Single Use | Zhejiang Kindly Medical Devices Co., Ltd. | 2022 | 1 | — |
| +7 | K213054 | Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe | Medline Industries, Inc. | 2022 | 0 | — |
| +7 | K221308 | Disposable Syringe with permanently attached needle, Safety Syringe with permanently… | Jiangxi Maidikang Medical Devices Co., Ltd. | 2022 | 0 | — |
| +7 | K221073 | Sterile Hypodermic Syringes for Single Use with Safety Needles | Sichuan Prius Biotechnology Co., Ltd. | 2022 | 0 | — |
| +7 | K213013 | Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe | Jeil Tech Co., Ltd. | 2022 | 0 | — |
| +7 | K220603 | Disposable Medical Safety Hypodermic Needle | Hantech Medical Device Co., Ltd. | 2022 | 0 | — |
| +7 | K213158 | Syringe with permanently attached needle | Berpu Medical Technology Co., Ltd. | 2022 | 0 | — |
| +7 | K220204 | Disposabel Syringe with permanently attached needle, Safety Syringe with permanently… | Anhui Tiankang Medical Technology Co., Ltd. | 2022 | 0 | — |
| +7 | K213535 | Sterile Safety Hypodermic Needles for Single Use | Zhejiang Kangkang Medical-Devices Co., Ltd. | 2022 | 0 | — |
| +7 | K212652 | Sterile Syringe with Fixed Safety Needle for Single Use | Gemtier Medical (Shanghai), Inc. | 2022 | 0 | — |
| +7 | K211329 | Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle… | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2021 | 3 | — |
| +7 | K211753 | Sterile Syringe With Safety Needle | Jiangxi Hongda Medical Equipment Group, Ltd. | 2021 | 0 | — |
| +7 | K210443 | PLPT LDV (Low Dead Volume) Sterile Syringe | Poonglim Pharmatech, Inc. | 2021 | 6 | — |
| +8 | K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle Tray | Sol-Millennium Medical, Inc. | 2026 | 0 | — |
| +8 | K250127 | TSK Syringe | Tsk Laboratory, Japan | 2025 | 0 | — |
| +8 | K250138 | Small Volume 0.2mL Syringe | Prosum Medical Limited | 2025 | 0 | — |
| +8 | K232950 | Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable… | Perfect Medical Industry (Vn) Co., Ltd. | 2024 | 1 | — |
| +8 | K231856 | TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) | Medexel Co.,Ltd | 2024 | 1 | — |
| +8 | K231165 | Shina Syringe; Shina Safety Syringe | Shina Med Corporation | 2023 | 0 | — |
| +8 | K221860 | PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead Volume) LL… | Poonglim Pharmatech, Inc. | 2023 | 1 | — |
| +8 | K221068 | Sterile Hypodermic Syringes for Single Use with Needles | Sichuan Prius Biotechnology Co., Ltd. | 2022 | 0 | — |
| +8 | K220083 | LDV ((Low Dead Volume )Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022 | 0 | — |
| +9 | K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe… | Exelint International, Co. | 2025 | 0 | — |
| +9 | K241190 | PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe; PLPT LDV (Low Dead Volume) LL… | Poonglim Pharmatech, Inc. | 2024 | 0 | — |