MRH · Pump, Infusion, Ophthalmic
General Hospital · 21 CFR 880.5725 · Class 2
Overview
| Product Code | MRH |
|---|---|
| Device Name | Pump, Infusion, Ophthalmic |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
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 | VIA360 Surgical System | New World Medical, Inc. | Feb 14, 2025 | SESE |
| K232214 | OMNI Surgical System | Sight Sciences, Inc. | Aug 25, 2023 | SESE |
| K213173 | TrabEx Pro | Microsurgical Technologies, Inc. | Jun 8, 2022 | SESE |
| K212797 | iPrime Viscodelivery System | Glaukos | Jan 6, 2022 | SESE |
| K211680 | Streamline Surgical System | New World Medical, Inc. | Oct 8, 2021 | SESE |
| K202678 | OMNI Surgical System | Sight Sciences, Inc. | Mar 1, 2021 | SESE |
| K201953 | OMNI PLUS Surgical System | Sight Sciences, Inc. | Aug 11, 2020 | SESE |
| K173332 | OMNI Surgical System | Sight Sciences, Inc. | Dec 21, 2017 | SESE |
| K171905 | VISCO 360 Viscosurgical System | Sight Sciences, Inc. | Jul 27, 2017 | SESE |
| K143205 | Viscoelastic Injector | Sight Sciences, Inc. | Dec 5, 2014 | SESE |
| K132494 | VISCOELASTIC INJECTOR | Sight Sciences, Inc. | Oct 22, 2013 | SESE |
| K050716 | ISCIENCE SURGICAL VISCOINJECTOR | Iscience Surgical Corporation | Apr 21, 2005 | SESE |
| K000420 | SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 | Retinalabs.Com | May 8, 2000 | SESE |
| K993039 | VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700) | Bausch & Lomb, Inc. | Jan 7, 2000 | SESE |
| K981907 | V.F.I.-VISCOUS FLUID INFUSION TUBING SET | Peregrine Surgical , Ltd. | Aug 4, 1998 | SESE |
| K974253 | CPD COMMANDER | Scieran Technologies, Inc. | Feb 25, 1998 | SESE |
| K972664 | STORZ MILLENNIUM VISCOUS FLUID SYSTEM | Storz Instrument Co. | Oct 10, 1997 | SESE |
| K971067 | DIGI-INJECTOR | Medical Instrument Development Laboratories, Inc. | Sep 19, 1997 | SESE |
| K963434 | 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
