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 Glaukos.

19
Total
19
Cleared
94d
Avg days
1996
Since
Stable submission activity - 1 submissions in the last 2 years
Consistent review times: 94d avg (recent)

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

19 devices
1–19 of 19
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

About Product Code MRH - Regulatory Context

510(k) Submission Activity

19 total 510(k) submissions under product code MRH since 1996, with 19 receiving FDA clearance (average review time: 94 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - MRH Product Code

FDA review times for MRH submissions have been consistent, averaging 94 days recently vs 94 days historically.

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