510(k) · Cleared
ClearedRigi10 Malleable Penile Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rigicon, Inc. · FAE Prosthesis, Penile
Cleared on Apr 15, 2019 as substantially equivalent to K040959 (Mentor Corp., 2004) after a 294-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Apr 15, 2019
- Review
- 294 days
- Class
- Class II
- Product code
- FAE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K900371 (1990). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 FAE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K040959 | Mentor Genesis Penile ProsthesisSummary page 4…Product Code : FAE 3) PREDICATE DEVICE Coloplast (formerly Mentor Corp.) Genesis Penile Prosthesis, K040959 This predicate has not been subject to a design-related recall. No reference dev… | 2004 |
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 29 years and passes through 2 companies; a new generation was cleared every 14.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All FAE devicesFAE Prosthesis, Penile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · FAE
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · FAE
Too few FAE 510(k)s in any year since 2007 to give a median.
Recalls per year · FAE
2in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAE
195in 2025
MAUDE reports naming product code FAE, 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 | — | 2 | 3 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 27 |
| 2011 | 0 | — | 0 | 87 |
| 2012 | 0 | — | 0 | 97 |
| 2013 | 0 | — | 0 | 108 |
| 2014 | 0 | — | 0 | 75 |
| 2015 | 0 | — | 0 | 98 |
| 2016 | 0 | — | 0 | 104 |
| 2017 | 0 | — | 0 | 123 |
| 2018 | 0 | — | 0 | 127 |
| 2019 | 2 | — | 0 | 221 |
| 2020 | 0 | — | 0 | 163 |
| 2021 | 0 | — | 0 | 167 |
| 2022 | 0 | — | 0 | 168 |
| 2023 | 0 | — | 0 | 160 |
| 2024 | 0 | — | 0 | 187 |
| 2025 | 0 | — | 0 | 195 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The malleable penile prosthesis is indicated for implantation into the corpora cavernosa of the penis in men who are diagnosed with erectile dysfunction. The prosthesis is implanted to provide adequate penile rigidity for sexual intercourse. The prosthesis is designed for the treatment of organic erectile dysfunction in men due to:
Pelvic fracture,Spinal cord injury or disease, Prostatectomy,Multiple sclerosis, Diabetes mellitus, Arteriosclerosis,Hypertensive vascular disease,Priapism,Peyronie’s disease,Selectively for psychogenic impotence.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181673 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181673: Rigi10 Malleable Penile Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181673
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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