MRD

FDA Product Code MRD: Mammary Sizer

Leading manufacturers include Mentor Worldwide, LLC, Motiva USA, LLC and Sientra, Inc..

13
Total
13
Cleared
100d
Avg days
1983
Since
Growing category - 2 submissions in the last 2 years vs 0 in the prior period
Consistent review times: 94d avg (recent)

FDA 510(k) Cleared Mammary Sizer Devices (Product Code MRD)

13 devices
1–13 of 13
Cleared Jan 13, 2025
MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer
K243271
Mentor Worldwide, LLC
General & Plastic Surgery · 89d
Cleared Sep 06, 2024
MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer
K241552
Mentor Worldwide, LLC
General & Plastic Surgery · 98d
Cleared Jun 02, 2021
NATRELLE INSPIRA Single Use Sizers for Gel Implants
K203229
Allergan
General & Plastic Surgery · 212d
Cleared Nov 16, 2020
Sientra OPUS Silicone Gel Breast Implant Sizer
K200706
Sientra, Inc.
General & Plastic Surgery · 243d
Cleared Feb 05, 2019
Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix
K183163
Motiva USA, LLC
General & Plastic Surgery · 82d

About Product Code MRD - Regulatory Context

510(k) Submission Activity

13 total 510(k) submissions under product code MRD since 1983, with 13 receiving FDA clearance (average review time: 100 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MRD Product Code

FDA review times for MRD submissions have been consistent, averaging 94 days recently vs 101 days historically.

MRD devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →