FDA product code MMX: Device, Percutaneous Retrieval
MMX is the FDA product code for device, percutaneous retrieval. It is a Class II device, regulated under 21 CFR 870.5150 and reviewed by the Cardiovascular panel. FDA has cleared 32 510(k) submissions under MMX, 7 in the last five years, from 19 different applicants. The average 510(k) review took 107 days (median 93); 91 days on average over the last three years. FDA has posted 1 recall for MMX devices.
Classification
| Field | Value |
|---|---|
| Device name | Device, Percutaneous Retrieval |
| Device class | Class II |
| Regulation | 21 CFR 870.5150 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MMX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 126 |
| 2018 | 1 | 127 |
| 2019 | 1 | 169 |
| 2020 | 2 | 76 |
| 2021 | 1 | 270 |
| 2022 | 3 | 140 |
| 2023 | 2 | 158 |
| 2024 | 1 | 28 |
| 2025 | 1 | 154 |
Top MMX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Merit Medical Systems, Inc. | 5 | 2020-01-17 |
| Argon Medical Devices, Inc. | 4 | 2023-09-07 |
| Cook Incorporated | 3 | 2023-05-16 |
| Radius Medical Technologies, Inc. | 3 | 2007-09-25 |
| LimFlow, Inc. | 2 | 2025-02-14 |
14 more applicants have MMX clearances. See the full list in Caduvo.
Most recent MMX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242776 | LimFlow, Inc. | LimFlow V-Ceiver | 2025-02-14 | 154 |
| K241259 | Medtronic, Inc. | Amplatz Goose Neck Snare Kit | 2024-06-03 | 28 |
| K232443 | Argon Medical Devices, Inc. | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit | 2023-09-07 | 24 |
| K222254 | Cook Incorporated | Gunther Tulip Vena Cava Filter Retrieval Set | 2023-05-16 | 293 |
| K222083 | LimFlow, Inc. | LimFlow V-Ceiver | 2022-08-09 | 25 |
Recalls for MMX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-07-17.
Frequently asked questions
What is FDA product code MMX?
MMX is the FDA product code for device, percutaneous retrieval. It is a Class II device, regulated under 21 CFR 870.5150 and reviewed by the Cardiovascular panel.
What device class is MMX?
Class II, regulation 21 CFR 870.5150. Typical premarket route: 510(k).
How long does a 510(k) take for product code MMX?
Across 32 cleared submissions the average was 107 days from receipt to decision (median 93).
Which companies have the most MMX clearances?
Merit Medical Systems, Inc. (5); Argon Medical Devices, Inc. (4); Cook Incorporated (3); Radius Medical Technologies, Inc. (3); LimFlow, Inc. (2).
Have MMX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2014-07-17.
Next steps
- Run an FDA pathway report with predicate devices for product code MMX
- Run a recall and safety report across every MMX manufacturer
- Watch product code MMX 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.