Atlas FDA

FMF

749 FDA 510(k) clearances · Product code

87 daysmedian time to decision
267 days90th percentile
749clearances measured

FDA profile

Official device name
Syringe, Piston
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5860
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 5,874 · 2022: 5,233 · 2023: 5,214 · 2024: 5,122 · 2025: 4,245 · 2026: 2,408
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Ultra-Fine™ SAFETY Insulin Syringe (K260208)embecta Medical II, LLC2026-07-13
Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe (K253110)Sol-Millennium Medical, Inc.2026-06-18
Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle (K260514)CMT Health PTE., Ltd.2026-06-12
Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) (K253112)Hlb Lifescience Co., Ltd.2026-05-21
Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) (K252279)Chirana T.Injecta,A.S.2026-04-17
Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe (K253068)CMT Health PTE., Ltd.2026-02-23
Instylla Delivery Kit (K253769)Instylla, Inc.2025-12-22
DuoprossTM Smart Cap (Type I) (K252518)Duopross Meditech Corporate2025-12-17
EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle (K251089)Exelint International, Co.2025-12-12
Verisafe Safety Retractable Insulin Syringes (K250192)Promisemed Hangzhou Meditech Co., Ltd.2025-12-10
Merit Syringe (K250853)Merit Medical Systems, Inc.2025-11-04
Sure-Fine Insulin Syringes (K250510)Shina Med Corporation2025-10-15
Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); Monojec (K243660)Cardinalhealth2025-08-22
BD Plastipak™ Syringe (K251350)Becton, Dickinson and Company2025-07-29
Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle (K252033)CMT Health PTE., Ltd.2025-07-25
3DOSE 1ml Syringe (K250733)Bimed Teknik Aletler Sanayi & Ticaret A.S.2025-07-03
GPS Advanced; GPS Advanced Cannula (K251648)Prosidyan, Inc.2025-06-24
GO-PEN® (K250262)Go-Pen Aps2025-04-24
GraftGun Universal Graft Delivery System (GDS) (K243580)SurGenTec, LLC2025-02-05
Insulin Syringes (K242434)Chirana T. Injecta2024-12-24
Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) (K241856)Hlb Lifescience Co., Ltd.2024-12-23
Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle (K242099)Sol-Millennium Medical, Inc.2024-10-22
Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle (K241821)Sol-Millennium Medical, Inc.2024-09-20
Tamper Evident Cap (K231095)International Medical Industries, Inc.2024-09-04
Disposable Pen Injector Assembly (K240961)Wuxi Nest Biotechnology Co., Ltd.2024-08-15
GPS Advanced; 5 cc GPS Advanced Cannula (K241426)Prosidyan, Inc.2024-07-10
Allograft Delivery Device (OFAC-C) (K233368)Bioventus, LLC2024-06-25
Pen Injector (K240774)Wuxi Nest Biotechnology Co., Ltd.2024-06-18
Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle (K232950)Perfect Medical Industry (Vn) Co., Ltd.2024-06-12
HWJECT Auto-disable syringe (K234024)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2024-03-19
Insulin Syringe (K233794)Spm Medicare Pvt. , Ltd.2024-03-06
Medline Luer Lock Syringes (K230235)Medline Industries, LP2024-02-16
SMB Luer lock disposable syringe (K231558)Smb Corporation of India2024-01-12
NavaClick Injection System (K231877)Lineage Biomedical, Inc.2023-11-30
Insulin Syringe (K230061)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2023-11-30
Revital Cady (K231519)Revital Healthcare (Epz) Limited2023-11-06
EpiZact (K233056)Guidestar Medical Devices2023-11-02
Disposable Sterile Syringe (K221777)Weihai Shengjie Medical Technology Co., Ltd.2023-10-06
VeriSafe Safety sterile syringes (K231792)Promisemed Hangzhou Meditech Co., Ltd.2023-09-28
BD Texium™ Needle-Free Syringe (K231888)Care Fusion2023-09-25
Sterile Auto-Disable Syringes with/without Needle for Single Use (K231727)Wepon Medical Technology Co., Ltd.2023-09-08
A-TAP (previously called Arthrotap) (K231900)Elcam Medical Acal2023-07-25
Hypodermic Syringes & Needle (K222925)Lifelong Meditech Private Limited2023-07-18
Avitus® DragonWing Large Volume Autograft Delivery System (K231456)Avitus Orthopaedics, Inc.2023-07-17
Avitus® Precision Autograft Delivery System (K230492)Avitus Orthopaedics, Inc.2023-06-26
Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use (K212857)Jiangsu Zhiyu Medical Instrument Co, Ltd.2023-05-09
Sol-Guard Auto-disable Syringe (K220713)Sol-Millennium Medical, Inc.2023-05-04
EpiFinder (K221974)Omeq Medical , Ltd.2023-04-16
Sterile Hypodermic Syringe for Single Use (K212207)Shandong Weigao Group Medical Polymer Co., Ltd.2023-03-23
Disposable Insulin Syringe (K222672)Hantech Medical Device Co., Ltd.2023-03-06
Insulin Syringe (K223453)Promisemed Hangzhou Meditech Co., Ltd.2023-03-02
CompuFlo Epidural Computer Controlled Anesthesia System (K221702)Milestone Scientific, Inc.2023-02-25
Sofjec (K212635)Hwajin Medical Co., Ltd.2023-02-13
Sterile Syringes for Single Use (K223678)Shanghai Kindly Enterprise Development Group Co., Ltd.2023-02-09
Insulin syringe with integrated needle DL (K203211)Dlp Medical Products, Corp.2023-02-09
Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe (K213054)Medline Industries, Inc.2022-12-09
Medwell Technology Ltd Syringes, various sizes (K212764)Medwell Technology, Ltd.2022-11-04
Insulin Syringes without needle (K221045)Berpu Medical Technology Co., Ltd.2022-11-03
Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle (K221308)Jiangxi Maidikang Medical Devices Co., Ltd.2022-10-17
Sol-M Luer Lock Syringe (K222744)Sol-Millennium Medical, Inc.2022-10-11
Sterile Hypodermic Syringes for Single Use with Needles (K221068)Sichuan Prius Biotechnology Co., Ltd.2022-10-04
Sterile Hypodermic Syringes for Single Use (K221079)Sichuan Prius Biotechnology Co., Ltd.2022-10-04
Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use (K212846)Jiangsu Jichun Medical Devices Co., Ltd.2022-08-30
Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle (K212033)Shandong Zhushi Pharmaceutical Group Co., Ltd.2022-08-17
InstaFill Graft Delivery System, SIGNIFY Bioactive (K221737)Globus Medical, Inc.2022-08-11
Syringe with permanently attached needle (K213158)Berpu Medical Technology Co., Ltd.2022-07-21
Pump Alignment Syringe (K220184)Jiangsu Caina Medical Co.,Ltd2022-07-21
Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle (K220204)Anhui Tiankang Medical Technology Co., Ltd.2022-07-14
Sterile Hypodermic Syringes for Single Use (K213811)Berpu Medical Technology Co., Ltd.2022-05-12
aboNT SYRINGE (K212677)Nipro Medical Corporation2022-04-15
Verifine Safety Syringe with Fixed Needle (K213560)Promisemed Hangzhou Meditech Co., Ltd.2022-04-05
Qitexio (K203738)Medex2022-03-14
Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use (K212920)Shandong Weigao Group Medical Polymer Co., Ltd.2022-03-11
BD Insulin Syringe (0.3mL) (K212499)Becton, Dickinson and Company2022-03-09
Sure-Fine Insulin Syringes (K210848)Shina Med Corporation2022-03-01
Instylla Delivery Kit (K213632)Instylla, Inc.2022-02-10
Sterile Auto-Disable Syringes with/without Needle for Single Use (K211210)Azur Medical Company, Inc.2022-01-27
Disposable Syringe with Needle (K211482)Shandong Qinkai Medical Industry Co., Ltd.2022-01-24
CHIRANA Insulin Syringes (K201044)Chirana T. Injecta2022-01-18
Sterile Syringe for Single Use (K210914)Jiangsu Suyun Medical Material Co., Ltd.2021-12-17
MiniLoad Syringe (K212544)Ocuject, LLC2021-10-13
Sterile syringes for single use with/without needle (K211211)Azur Medical Company, Inc.2021-10-07
Sterile hypodermic syringes for single use (K211728)Jiangsu Kangyou Medical Instrument Co., Ltd.2021-10-05
TrueCare Biomedix Tamper Evident Cap (K210818)Us Infusion Inc. D/B/A Truecare Biomedix-USA2021-09-15
Sterile syringe for single use with/without needle (K210227)Zhejiang Kangkang Medical-Devices Co., Ltd.2021-09-10
Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes (K211242)Promisemed Hangzhou Meditech Co., Ltd.2021-09-09
Verifine Mechanical Safety Insulin Syringe (K210712)Promisemed Hangzhou Meditech Co., Ltd.2021-09-08
PreferX Delivery System (K210997)Md3, LLC2021-09-07
Disposable Sterile Syringe, Disposable Sterile Syringe with Needle (K210991)Guangdong Antmed Co., Ltd.2021-08-26
Auto Disable Syringe (K210464)Anhui Tiankang Medical Technology Co., Ltd.2021-08-24
BD Flu+ Syringe (K203359)Becton, Dickinson and Company2021-07-28
SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX (K210103)Lifelong Meditech Private Limited2021-07-16
1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock (K210200)Set Medikal Sanayi VE Ticaret Anonim Sirketi2021-05-14
MicroDose Injector (K203264)Medone Surgical, Inc.2021-04-26
MiniLoad Syringe (K202432)Ocuject, LLC2021-02-19
BD Hypodermic Syringe (K203453)Becton, Dickinson and Company2021-01-25
Nanum Syringe (K201930)Nanum Company Co., Ltd.2021-01-17
Instylla Delivery Kit (K202544)Instylla, Inc.2021-01-07
Insulin Syringe (K193273)Promisemed Hangzhou Meditech Co., Ltd.2021-01-05
S dispensing line (K192770)Aea Srl2020-12-17
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