510(k) · Cleared
ClearedPre-Formed Penile Silicone Block
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Medical Devices, Inc. · MIB Elastomer, Silicone Block
Cleared on Jan 23, 2019 as substantially equivalent to K162624 (International Medical Devices, Inc., 2017) after a 243-day review. Its family tree reaches back 2 generations to 2002. 3 later devices descend from it.
- Decided
- Jan 23, 2019
- Review
- 243 days
- Class
- Class II
- Product code
- MIB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K021839 (2002). 5 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK021839 Aart Gluteal ImplantAesthetic and Reconstructive Technologies, Inc. · 2002 · Recalled
- 1 generation backK162624 Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2017
- This deviceK181387 Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK220760 Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK223051 Pre-Formed Silicone BlockInternational Medical Devices, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK200073 AugMENTA Penile ImplantAugmenta, LLC · 2022
Most influential descendants
Showing 3 of 3 · See all- K220760Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2022 · cites it directly1descendant
- K223051Pre-Formed Silicone BlockInternational Medical Devices, Inc. · 2023 · cites it directly0descendants
- K200073AugMENTA Penile ImplantAugmenta, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021839 | Aart Gluteal Implant | Aesthetic and Reconstructive Technologies, Inc. | 2002 | 1 |
| −1 | K162624 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2017 | — |
| 0 (this device) | K181387 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2019 | — |
| +1 | K220760 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2022 | — |
| +1 | K223051 | Pre-Formed Silicone Block | International Medical Devices, Inc. | 2023 | — |
| +1 | K200073 | AugMENTA Penile Implant | Augmenta, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MIB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MIB device
- #1 K241150 MISTI Silicone Implantscore 8.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K162624 | Pre-Formed Penile Silicone BlockSummary page 4…Name / Manufacturer Primary Number Predicate K162624 Pre‐Formed Penile Silicone Block / International Medical Devices, Inc. DEVICE DESCRIPTION The Pre‐Formed Penile Si… | 2017 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 14.5 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K220760 (International Medical Devices, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K162624.
How does its category compare?
All MIB devicesMIB Elastomer, Silicone Block: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · MIB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MIB
102in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MIB
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MIB
18in 2025
MAUDE reports naming product code MIB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 10 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 3 | 102 | 0 | 19 |
| 2023 | 1 | — | 0 | 74 |
| 2024 | 1 | — | 0 | 32 |
| 2025 | 0 | — | 3 | 18 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Pre-Formed Penile Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is
contoured at the surgeon’s discretion to create a custom implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181387 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181387: Pre-Formed Penile Silicone Block.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181387
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026