FDA product code MIB: Elastomer, Silicone Block
MIB is the FDA product code for elastomer, silicone block. It is a Class II device, regulated under 21 CFR 874.3620 and reviewed by the General and Plastic Surgery panel. FDA has cleared 45 510(k) submissions under MIB, 5 in the last five years, from 24 different applicants. The average 510(k) review took 113 days (median 71); 90 days on average over the last three years. FDA has posted 3 recalls for MIB devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Elastomer, Silicone Block |
| Device class | Class II |
| Regulation | 21 CFR 874.3620 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MIB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 134 |
| 2018 | 1 | 268 |
| 2019 | 1 | 243 |
| 2020 | 1 | 227 |
| 2022 | 3 | 384 |
| 2023 | 1 | 127 |
| 2024 | 1 | 90 |
Top MIB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| International Medical Devices, Inc. | 4 | 2023-02-03 |
| Hanson Medical, Inc. | 4 | 2003-04-21 |
| Aesthetic and Reconstructive Technologies, Inc. | 4 | 2002-08-26 |
| Specialty Surgical Products, Inc. | 3 | 1998-08-12 |
| Silimed, LLC | 3 | 1998-07-09 |
19 more applicants have MIB clearances. See the full list in Caduvo.
Most recent MIB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241150 | Keosan Trading Co. | MISTI Silicone Implant | 2024-07-24 | 90 |
| K223051 | International Medical Devices, Inc. | Pre-Formed Silicone Block | 2023-02-03 | 127 |
| K222748 | Shineo Technology Co., Ltd. | ShiNeo Silicone Implant | 2022-12-23 | 102 |
| K200073 | Augmenta, LLC | AugMENTA Penile Implant | 2022-09-30 | 990 |
| K220760 | International Medical Devices, Inc. | Pre-Formed Penile Silicone Block | 2022-05-13 | 59 |
Recalls for MIB devices
3 product recalls in 1 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-09-26.
| Year | Recalls |
|---|---|
| 2025 | 3 |
Frequently asked questions
What is FDA product code MIB?
MIB is the FDA product code for elastomer, silicone block. It is a Class II device, regulated under 21 CFR 874.3620 and reviewed by the General and Plastic Surgery panel.
What device class is MIB?
Class II, regulation 21 CFR 874.3620. Typical premarket route: 510(k).
How long does a 510(k) take for product code MIB?
Across 45 cleared submissions the average was 113 days from receipt to decision (median 71).
Which companies have the most MIB clearances?
International Medical Devices, Inc. (4); Hanson Medical, Inc. (4); Aesthetic and Reconstructive Technologies, Inc. (4); Specialty Surgical Products, Inc. (3); Silimed, LLC (3).
Have MIB devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2025-09-26.
Next steps
- Run an FDA pathway report with predicate devices for product code MIB
- Run a recall and safety report across every MIB manufacturer
- Watch product code MIB 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.
All General and Plastic Surgery product codes · FDA product code lookup