FDA product code MRC: Products, Contact Lens Care, Rigid Gas Permeable
MRC is the FDA product code for products, contact lens care, rigid gas permeable. It is a Class II device, regulated under 21 CFR 886.5918 and reviewed by the Ophthalmic panel. FDA has cleared 33 510(k) submissions under MRC, 1 in the last five years, from 18 different applicants. The average 510(k) review took 111 days (median 84); 113 days on average over the last three years. FDA has posted 4 recalls for MRC devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Products, Contact Lens Care, Rigid Gas Permeable |
| Device class | Class II |
| Regulation | 21 CFR 886.5918 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MRC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 54 |
| 2018 | 3 | 77 |
| 2019 | 1 | 268 |
| 2020 | 2 | 158 |
| 2025 | 1 | 113 |
Compare with all 510(k) review times · Search every MRC clearance
Top MRC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Menicon Co, Ltd. | 6 | 2017-11-16 |
| Ciba Vision Corporation | 5 | 2003-02-28 |
| Bausch & Lomb, Incorporated | 4 | 2020-09-23 |
| Lobob Laboratories, Inc. | 3 | 2002-01-15 |
| Alcon Universal, Ltd. | 2 | 2000-07-03 |
13 more applicants have MRC clearances. See the full list in Caduvo.
Most recent MRC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251876 | Ophtecs Corporation | cleadew GP hydra one | 2025-10-09 | 113 |
| K200416 | Bausch & Lomb, Incorporated | Boston One Step Liquid Enzymatic Cleaner | 2020-09-23 | 216 |
| K201069 | Dry Eye Innovations, LLC | VibrantVue Scleral Saline | 2020-07-31 | 100 |
| K182984 | Omnivision AG | MaxiTears Contacts PF | 2019-07-24 | 268 |
| K181566 | Contamac, Ltd. | Nutrifill | 2018-10-22 | 130 |
Recalls for MRC devices
4 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-05-15.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code MRC?
MRC is the FDA product code for products, contact lens care, rigid gas permeable. It is a Class II device, regulated under 21 CFR 886.5918 and reviewed by the Ophthalmic panel.
What device class is MRC?
Class II, regulation 21 CFR 886.5918. Typical premarket route: 510(k).
How long does a 510(k) take for product code MRC?
Across 33 cleared submissions the average was 111 days from receipt to decision (median 84).
Which companies have the most MRC clearances?
Menicon Co, Ltd. (6); Ciba Vision Corporation (5); Bausch & Lomb, Incorporated (4); Lobob Laboratories, Inc. (3); Alcon Universal, Ltd. (2).
Have MRC devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2025-05-15.
Next steps
- Run an FDA pathway report with predicate devices for product code MRC
- Run a recall and safety report across every MRC manufacturer
- Watch product code MRC 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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