Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5860](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5860) → FMF — Syringe, Piston # FMF · Syringe, Piston _General Hospital · 21 CFR 880.5860 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF ## Overview - **Product Code:** FMF - **Device Name:** Syringe, Piston - **Regulation:** [21 CFR 880.5860](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5860) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) - **3rd-party reviewable:** yes ## Identification A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 749) Showing 20 most recent of 749 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252279](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K252279.md) | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) | Chirana T.Injecta,A.S. | Apr 17, 2026 | SESE | | [K253068](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K253068.md) | Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe | CMT Health PTE., Ltd. | Feb 23, 2026 | SESE | | [K253769](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K253769.md) | Instylla Delivery Kit | Instylla, Inc. | Dec 22, 2025 | SESE | | [K252518](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K252518.md) | DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate | Dec 17, 2025 | SESE | | [K251089](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K251089.md) | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle | Exelint International, Co. | Dec 12, 2025 | SESE | | [K250192](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K250192.md) | Verisafe Safety Retractable Insulin Syringes | Promisemed Hangzhou Meditech Co., Ltd. | Dec 10, 2025 | SESE | | [K250853](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K250853.md) | Merit Syringe | Merit Medical Systems, Inc. | Nov 4, 2025 | SESE | | [K250510](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K250510.md) | Sure-Fine Insulin Syringes | Shina Med Corporation | Oct 15, 2025 | SESE | | [K243660](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K243660.md) | 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 | Cardinalhealth | Aug 22, 2025 | SESE | | [K251350](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K251350.md) | BD Plastipak™ Syringe | Becton, Dickinson and Company | Jul 29, 2025 | SESE | | [K252033](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K252033.md) | Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle | CMT Health PTE., Ltd. | Jul 25, 2025 | SESE | | [K250733](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K250733.md) | 3DOSE 1ml Syringe | Bimed Teknik Aletler Sanayi & Ticaret A.S. | Jul 3, 2025 | SESE | | [K251648](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K251648.md) | GPS Advanced; GPS Advanced Cannula | Prosidyan, Inc. | Jun 24, 2025 | SESE | | [K250262](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K250262.md) | GO-PEN® | Go-Pen Aps | Apr 24, 2025 | SESE | | [K243580](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K243580.md) | GraftGun Universal Graft Delivery System (GDS) | SurGenTec, LLC | Feb 5, 2025 | SESE | | [K242434](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K242434.md) | Insulin Syringes | Chirana T. Injecta | Dec 24, 2024 | SESE | | [K241856](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K241856.md) | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) | Hlb Lifescience Co., Ltd. | Dec 23, 2024 | SESE | | [K242099](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K242099.md) | Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle | Sol-Millennium Medical, Inc. | Oct 22, 2024 | SESE | | [K241821](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K241821.md) | Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle | Sol-Millennium Medical, Inc. | Sep 20, 2024 | SESE | | [K231095](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K231095.md) | Tamper Evident Cap | International Medical Industries, Inc. | Sep 4, 2024 | SESE | ## Top Applicants - Bd Becton Dickinson Vacutainer Systems Preanalytic — 23 clearances - Sherwood Medical Co. — 20 clearances - Becton, Dickinson and Company — 13 clearances - Merit Medical Systems, Inc. — 10 clearances - Terumo Medical Corp. — 10 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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