510(k) · Cleared
ClearedAugMENTA Penile Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Augmenta, LLC · MIB Elastomer, Silicone Block
Cleared on Sep 30, 2022 as substantially equivalent to K181387 (International Medical Devices, Inc., 2019) after a 990-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Sep 30, 2022
- Review
- 990 days
- Class
- Class II
- Product code
- MIB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K021839 (2002). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK021839 Aart Gluteal ImplantAesthetic and Reconstructive Technologies, Inc. · 2002 · Recalled
- 2 generations backK162624 Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2017
- 1 generation backK181387 Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2019
- This deviceK200073 AugMENTA Penile ImplantAugmenta, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K021839 | Aart Gluteal Implant | Aesthetic and Reconstructive Technologies, Inc. | 2002 | 1 |
| −2 | K162624 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2017 | — |
| −1 | K181387 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2019 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K181387 | Pre-Formed Penile Silicone BlockSummary page 4…4.3620 Regulatory Classification: 2 Product Code: MIB Predicate Device: Pre-Formed Penile Silicone Block (K181387) The predicate device has not been subject of a design-related recall. Device Description: The Augmen… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K181387.
How does its category compare?
All MIB devicesMIB Elastomer, Silicone Block: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Augmenta Penile Implant is an implantable device intended for use in the cosmetic correction of soft tissue deformities, and is trimmed to length at the surgeon's discretion for a custom implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200073 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200073: AugMENTA Penile Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200073
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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