Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MRH — Predicate Candidate Screening
20 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
252 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253760 | OMNI Ultra Surgical System (1-110) | Sight Sciences, Inc. | 2026-08-04 | 252 | 0 |
| K243503 | VIA360™ Surgical System | New World Medical, Inc. | 2025-02-14 | 94 | 0 |
| K232214 | OMNI Surgical System | Sight Sciences, Inc. | 2023-08-25 | 30 | 0 |
| K213173 | TrabEx Pro | Microsurgical Technologies, Inc. | 2022-06-08 | 253 | 0 |
| K212797 | iPrime Viscodelivery System | Glaukos | 2022-01-06 | 126 | 0 |
| K211680 | Streamline Surgical System | New World Medical, Inc. | 2021-10-08 | 129 | 0 |
| K202678 | OMNI Surgical System | Sight Sciences, Inc. | 2021-03-01 | 167 | 0 |
| K201953 | OMNI PLUS Surgical System | Sight Sciences, Inc. | 2020-08-11 | 28 | 0 |
| K173332 | OMNI Surgical System | Sight Sciences, Inc. | 2017-12-21 | 59 | 0 |
| K171905 | VISCO 360 Viscosurgical System | Sight Sciences, Inc. | 2017-07-27 | 31 | 0 |
| K143205 | Viscoelastic Injector | Sight Sciences, Inc. | 2014-12-05 | 28 | 0 |
| K132494 | VISCOELASTIC INJECTOR | Sight Sciences, Inc. | 2013-10-22 | 74 | 0 |
| K050716 | ISCIENCE SURGICAL VISCOINJECTOR | Iscience Surgical Corporation | 2005-04-21 | 31 | 0 |
| K000420 | SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10 | Retinalabs.Com | 2000-05-08 | 90 | 0 |
| K993039 | VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700) | Bausch & Lomb, Inc. | 2000-01-07 | 119 | 0 |
| K981907 | V.F.I.-VISCOUS FLUID INFUSION TUBING SET | Peregrine Surgical , Ltd. | 1998-08-04 | 64 | 0 |
| K974253 | CPD COMMANDER | Scieran Technologies, Inc. | 1998-02-25 | 104 | 0 |
| K972664 | STORZ MILLENNIUM VISCOUS FLUID SYSTEM | Storz Instrument Co. | 1997-10-10 | 86 | 0 |
| K971067 | DIGI-INJECTOR | Medical Instrument Development Laboratories, Inc. | 1997-09-19 | 179 | 0 |
| K963434 | VISCOUS FLUID SYSTEM | Escalon Trek Medical | 1996-11-25 | 87 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda