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 880.5725](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5725) → MRH — Pump, Infusion, Ophthalmic # MRH · Pump, Infusion, Ophthalmic _General Hospital · 21 CFR 880.5725 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH ## Overview - **Product Code:** MRH - **Device Name:** Pump, Infusion, Ophthalmic - **Regulation:** [21 CFR 880.5725](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5725) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) ## Identification An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (19 of 19) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K243503](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH/K243503.md) | VIA360™ Surgical System | New World Medical, Inc. | Feb 14, 2025 | SESE | | [K232214](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH/K232214.md) | OMNI Surgical System | Sight Sciences, Inc. | Aug 25, 2023 | SESE | | [K213173](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH/K213173.md) | TrabEx Pro | Microsurgical Technologies, Inc. | Jun 8, 2022 | SESE | | [K212797](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH/K212797.md) | iPrime Viscodelivery System | Glaukos | Jan 6, 2022 | SESE | | [K211680](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH/K211680.md) | Streamline Surgical System | New World Medical, Inc. | Oct 8, 2021 | SESE | | [K202678](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH/K202678.md) | OMNI Surgical System | Sight Sciences, Inc. | Mar 1, 2021 | SESE | | [K201953](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH/K201953.md) | OMNI PLUS Surgical System | Sight Sciences, Inc. | Aug 11, 2020 | SESE | | [K173332](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH/K173332.md) | OMNI Surgical System | Sight Sciences, Inc. | Dec 21, 2017 | SESE | | [K171905](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH/K171905.md) | VISCO 360 Viscosurgical System | Sight Sciences, Inc. | Jul 27, 2017 | SESE | | [K143205](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH/K143205.md) | Viscoelastic Injector | Sight Sciences, Inc. | Dec 5, 2014 | SESE | | [K132494](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH/K132494.md) | VISCOELASTIC INJECTOR | Sight Sciences, Inc. | Oct 22, 2013 | SESE | | [K050716](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH/K050716.md) | ISCIENCE SURGICAL VISCOINJECTOR | Iscience Surgical Corporation | Apr 21, 2005 | SESE | | [K000420](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH/K000420.md) | SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 | Retinalabs.Com | May 8, 2000 | SESE | | [K993039](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH/K993039.md) | VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700) | Bausch & Lomb, Inc. | Jan 7, 2000 | SESE | | [K981907](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH/K981907.md) | V.F.I.-VISCOUS FLUID INFUSION TUBING SET | Peregrine Surgical , Ltd. | Aug 4, 1998 | SESE | | [K974253](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH/K974253.md) | CPD COMMANDER | Scieran Technologies, Inc. | Feb 25, 1998 | SESE | | [K972664](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH/K972664.md) | STORZ MILLENNIUM VISCOUS FLUID SYSTEM | Storz Instrument Co. | Oct 10, 1997 | SESE | | [K971067](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH/K971067.md) | DIGI-INJECTOR | Medical Instrument Development Laboratories, Inc. | Sep 19, 1997 | SESE | | [K963434](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH/K963434.md) | VISCOUS FLUID SYSTEM | Escalon Trek Medical | Nov 25, 1996 | SESE | ## Top Applicants - Sight Sciences, Inc. — 7 clearances - New World Medical, Inc. — 2 clearances - Bausch & Lomb, Inc. — 1 clearance - Escalon Trek Medical — 1 clearance - Glaukos — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MRH) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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