FDA product code MPA: Endoilluminator
MPA is the FDA product code for endoilluminator. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Ophthalmic panel. FDA has cleared 41 510(k) submissions under MPA, 4 in the last five years, from 26 different applicants. The average 510(k) review took 133 days (median 90); 252 days on average over the last three years. FDA has posted 1 recall for MPA devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Endoilluminator |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MPA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 340 |
| 2023 | 1 | 275 |
| 2024 | 2 | 198 |
| 2026 | 1 | 305 |
Compare with all 510(k) review times · Search every MPA clearance
Top MPA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Peregrine Surgical , Ltd. | 5 | 2015-09-11 |
| Gamp & Assoc. | 5 | 1996-01-05 |
| American Medical Devices, Inc. | 3 | 1997-06-24 |
| M.B. Industries, Inc. | 3 | 1997-05-13 |
| Synergetics, Inc. | 2 | 2003-11-24 |
21 more applicants have MPA clearances. See the full list in Caduvo.
Most recent MPA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253468 | Nova Eye, Inc. | Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A) | 2026-08-10 | 305 |
| K242184 | Alcon Laboratories, Inc. | Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); | 2024-12-04 | 132 |
| K233653 | Peregrine Surgical, LLC | Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) | 2024-08-05 | 265 |
| K221872 | Nova Eye Inc. (Business Name Nova Eye Medical) | ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System | 2023-03-30 | 275 |
| K202670 | Oculight , Ltd. | Nam illumination probe with chopper | 2021-08-20 | 340 |
Recalls for MPA devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-08-05.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code MPA?
MPA is the FDA product code for endoilluminator. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Ophthalmic panel.
What device class is MPA?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code MPA?
Across 41 cleared submissions the average was 133 days from receipt to decision (median 90).
Which companies have the most MPA clearances?
Peregrine Surgical , Ltd. (5); Gamp & Assoc. (5); American Medical Devices, Inc. (3); M.B. Industries, Inc. (3); Synergetics, Inc. (2).
Have MPA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-08-05.
Next steps
- Run an FDA pathway report with predicate devices for product code MPA
- Run a recall and safety report across every MPA manufacturer
- Watch product code MPA 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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