FDA product code MRD: Mammary Sizer
MRD is the FDA product code for mammary sizer. It is a Unclassified device, reviewed by the General and Plastic Surgery panel. FDA has cleared 13 510(k) submissions under MRD, 2 in the last five years, from 9 different applicants. The average 510(k) review took 100 days (median 87); 94 days on average over the last three years. FDA has posted 4 recalls for MRD devices.
Classification
| Field | Value |
|---|---|
| Device name | Mammary Sizer |
| Device class | Unclassified |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for MRD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 82 |
| 2020 | 1 | 243 |
| 2021 | 1 | 212 |
| 2024 | 1 | 98 |
| 2025 | 1 | 89 |
Compare with all 510(k) review times · Search every MRD clearance
Top MRD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mentor Worldwide, LLC | 4 | 2025-01-13 |
| Specialty Surgical Products, Inc. | 2 | 1999-02-12 |
| Allergan | 1 | 2021-06-02 |
| Sientra, Inc. | 1 | 2020-11-16 |
| Motiva USA, LLC | 1 | 2019-02-05 |
4 more applicants have MRD clearances. See the full list in Caduvo.
Most recent MRD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243271 | Mentor Worldwide, LLC | MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Enhance Single Use Gel Sizer | 2025-01-13 | 89 |
| K241552 | Mentor Worldwide, LLC | MENTOR MemoryGel Enhance Single Use Gel Sizer | 2024-09-06 | 98 |
| K203229 | Allergan | NATRELLE INSPIRA Single Use Sizers for Gel Implants | 2021-06-02 | 212 |
| K200706 | Sientra, Inc. | Sientra OPUS Silicone Gel Breast Implant Sizer | 2020-11-16 | 243 |
| K183163 | Motiva USA, LLC | Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix | 2019-02-05 | 82 |
Recalls for MRD devices
4 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-11-06.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code MRD?
MRD is the FDA product code for mammary sizer. It is a Unclassified device, reviewed by the General and Plastic Surgery panel.
What device class is MRD?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code MRD?
Across 13 cleared submissions the average was 100 days from receipt to decision (median 87).
Which companies have the most MRD clearances?
Mentor Worldwide, LLC (4); Specialty Surgical Products, Inc. (2); Allergan (1); Sientra, Inc. (1); Motiva USA, LLC (1).
Have MRD devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2019-11-06.
Next steps
- Run an FDA pathway report with predicate devices for product code MRD
- Run a recall and safety report across every MRD manufacturer
- Watch product code MRD 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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