Atlas FDA

MRH

20 FDA 510(k) clearances · Product code

90 daysmedian time to decision
252 days90th percentile
20clearances measured

FDA profile

Official device name
Pump, Infusion, Ophthalmic
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Medical specialty
General Hospital
Adverse events (MAUDE)
2017: 28 · 2022: 16 · 2023: 31 · 2024: 20 · 2026: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
OMNI Ultra Surgical System (1-110) (K253760)Sight Sciences, Inc.2026-08-04
VIA360™ Surgical System (K243503)New World Medical, Inc.2025-02-14
OMNI Surgical System (K232214)Sight Sciences, Inc.2023-08-25
TrabEx Pro (K213173)Microsurgical Technologies, Inc.2022-06-08
iPrime Viscodelivery System (K212797)Glaukos2022-01-06
Streamline Surgical System (K211680)New World Medical, Inc.2021-10-08
OMNI Surgical System (K202678)Sight Sciences, Inc.2021-03-01
OMNI PLUS Surgical System (K201953)Sight Sciences, Inc.2020-08-11
OMNI Surgical System (K173332)Sight Sciences, Inc.2017-12-21
VISCO 360 Viscosurgical System (K171905)Sight Sciences, Inc.2017-07-27
Viscoelastic Injector (K143205)Sight Sciences, Inc.2014-12-05
VISCOELASTIC INJECTOR (K132494)Sight Sciences, Inc.2013-10-22
ISCIENCE SURGICAL VISCOINJECTOR (K050716)Iscience Surgical Corporation2005-04-21
SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 (K000420)Retinalabs.Com2000-05-08
VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700) (K993039)Bausch & Lomb, Inc.2000-01-07
V.F.I.-VISCOUS FLUID INFUSION TUBING SET (K981907)Peregrine Surgical , Ltd.1998-08-04
CPD COMMANDER (K974253)Scieran Technologies, Inc.1998-02-25
STORZ MILLENNIUM VISCOUS FLUID SYSTEM (K972664)Storz Instrument Co.1997-10-10
DIGI-INJECTOR (K971067)Medical Instrument Development Laboratories, Inc.1997-09-19
VISCOUS FLUID SYSTEM (K963434)Escalon Trek Medical1996-11-25

Track MRH automatically

Every clearance here is in the API, with alerts when new ones post.