FDA product code MRH: Pump, Infusion, Ophthalmic
MRH is the FDA product code for pump, infusion, ophthalmic. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the Ophthalmic panel. FDA has cleared 20 510(k) submissions under MRH, 5 in the last five years, from 12 different applicants. The average 510(k) review took 102 days (median 88); 173 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Pump, Infusion, Ophthalmic |
| Device class | Class II |
| Regulation | 21 CFR 880.5725 |
| Review panel | OP — Ophthalmic |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for MRH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 45 |
| 2020 | 1 | 28 |
| 2021 | 2 | 148 |
| 2022 | 2 | 190 |
| 2023 | 1 | 30 |
| 2025 | 1 | 94 |
| 2026 | 1 | 252 |
Compare with all 510(k) review times · Search every MRH clearance
Top MRH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sight Sciences, Inc. | 8 | 2026-08-04 |
| New World Medical, Inc. | 2 | 2025-02-14 |
| Microsurgical Technologies, Inc. | 1 | 2022-06-08 |
| Glaukos | 1 | 2022-01-06 |
| Iscience Surgical Corporation | 1 | 2005-04-21 |
7 more applicants have MRH clearances. See the full list in Caduvo.
Most recent MRH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253760 | Sight Sciences, Inc. | OMNI Ultra Surgical System (1-110) | 2026-08-04 | 252 |
| K243503 | New World Medical, Inc. | VIA360 Surgical System | 2025-02-14 | 94 |
| K232214 | Sight Sciences, Inc. | OMNI Surgical System | 2023-08-25 | 30 |
| K213173 | Microsurgical Technologies, Inc. | TrabEx Pro | 2022-06-08 | 253 |
| K212797 | Glaukos | iPrime Viscodelivery System | 2022-01-06 | 126 |
Recalls for MRH devices
openFDA lists no recalls for product code MRH.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- A4220 — Refill kit for implantable infusion pump
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement
Frequently asked questions
What is FDA product code MRH?
MRH is the FDA product code for pump, infusion, ophthalmic. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the Ophthalmic panel.
What device class is MRH?
Class II, regulation 21 CFR 880.5725. Typical premarket route: 510(k).
How long does a 510(k) take for product code MRH?
Across 20 cleared submissions the average was 102 days from receipt to decision (median 88).
Which companies have the most MRH clearances?
Sight Sciences, Inc. (8); New World Medical, Inc. (2); Microsurgical Technologies, Inc. (1); Glaukos (1); Iscience Surgical Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MRH
- Run a recall and safety report across every MRH manufacturer
- Watch product code MRH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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