MRH · Class II · 21 CFR 880.5725

FDA Product Code MRH: Pump, Infusion, Ophthalmic

Leading manufacturers include Sight Sciences, Inc., New World Medical, Inc. and Retinalabs.Com.

20
Total
20
Cleared
102d
Avg days
1996
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 173d recently vs 94d historically

FDA 510(k) Cleared Pump, Infusion, Ophthalmic Devices (Product Code MRH)

20 devices
1–20 of 20
Cleared Aug 04, 2026
OMNI Ultra Surgical System (1-110)
K253760
Sight Sciences, Inc.
Ophthalmic · 252d
Cleared Feb 14, 2025
VIA360™ Surgical System
K243503
New World Medical, Inc.
Ophthalmic · 94d
Cleared Aug 25, 2023
OMNI Surgical System
K232214
Sight Sciences, Inc.
Ophthalmic · 30d
Cleared Jun 08, 2022
TrabEx Pro
K213173
Microsurgical Technologies, Inc.
Ophthalmic · 253d
Cleared Jan 06, 2022
iPrime Viscodelivery System
K212797
Glaukos
Ophthalmic · 126d
Cleared Oct 08, 2021
Streamline Surgical System
K211680
New World Medical, Inc.
Ophthalmic · 129d
Cleared Mar 01, 2021
OMNI Surgical System
K202678
Sight Sciences, Inc.
Ophthalmic · 167d
Cleared Aug 11, 2020
OMNI PLUS Surgical System
K201953
Sight Sciences, Inc.
Ophthalmic · 28d
Cleared Dec 21, 2017
OMNI Surgical System
K173332
Sight Sciences, Inc.
Ophthalmic · 59d
Cleared Jul 27, 2017
VISCO 360 Viscosurgical System
K171905
Sight Sciences, Inc.
Ophthalmic · 31d
Cleared Dec 05, 2014
Viscoelastic Injector
K143205
Sight Sciences, Inc.
Ophthalmic · 28d
Cleared Oct 22, 2013
VISCOELASTIC INJECTOR
K132494
Sight Sciences, Inc.
Ophthalmic · 74d
Cleared Apr 21, 2005
ISCIENCE SURGICAL VISCOINJECTOR
K050716
Iscience Surgical Corporation
Ophthalmic · 31d
Cleared May 08, 2000
SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003
K000420
Retinalabs.Com
Ophthalmic · 90d
Cleared Jan 07, 2000
VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)
K993039
Bausch & Lomb, Inc.
Ophthalmic · 119d
Cleared Aug 04, 1998
V.F.I.-VISCOUS FLUID INFUSION TUBING SET
K981907
Peregrine Surgical , Ltd.
Ophthalmic · 64d
Cleared Feb 25, 1998
CPD COMMANDER
K974253
Scieran Technologies, Inc.
Ophthalmic · 104d
Cleared Oct 10, 1997
STORZ MILLENNIUM VISCOUS FLUID SYSTEM
K972664
Storz Instrument Co.
Ophthalmic · 86d
Cleared Sep 19, 1997
DIGI-INJECTOR
K971067
Medical Instrument Development Laboratories, Inc.
Ophthalmic · 179d
Cleared Nov 25, 1996
VISCOUS FLUID SYSTEM
K963434
Escalon Trek Medical
Ophthalmic · 87d

About Product Code MRH - Regulatory Context

510(k) Submission Activity

20 total 510(k) submissions under product code MRH since 1996, with 20 receiving FDA clearance (average review time: 102 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MRH Product Code

Recent submissions under MRH have taken an average of 173 days to reach a decision - up from 94 days historically. Manufacturers should account for longer review timelines in current project planning.

MRH devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →