510(k) · Cleared
ClearedConstrictor Ring for Penile Erection
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Performance, Inc. · LKY Device, External Penile Rigidity
Cleared on Apr 27, 1989 after a 55-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Apr 27, 1989
- Review
- 55 days
- Class
- Class II
- Product code
- LKY
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK891125 Constrictor Ring for Penile ErectionPerformance, Inc. · 1989
- Descendant · cites it directly · 1 of its ownK981343 Erco-RibbonErcons, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK990008 Erco-Ribbon -CErcons, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK974082 The Performance Plus Confidence Rings, the Performance Plus Erection…Performance Plus, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK972353 Erco-RibbonErcons, Inc. · 1997
Most influential descendants
Showing 4 of 4 · See all- K981343Erco-RibbonErcons, Inc. · 1998 · cites it directly1descendant
- K990008Erco-Ribbon -CErcons, Inc. · 1999 · cites it directly0descendants
- K974082The Performance Plus Confidence Rings, the Performance Plus Erection Inducer DevicePerformance Plus, Inc. · 1998 · cites it directly0descendants
- K972353Erco-RibbonErcons, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K891125 | Constrictor Ring for Penile Erection | Performance, Inc. | 1989 | — |
| +1 | K981343 | Erco-Ribbon | Ercons, Inc. | 1998 | — |
| +1 | K990008 | Erco-Ribbon -C | Ercons, Inc. | 1999 | — |
| +1 | K974082 | The Performance Plus Confidence Rings, the Performance Plus Erection Inducer… | Performance Plus, Inc. | 1998 | — |
| +1 | K972353 | Erco-Ribbon | Ercons, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LKY? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
4 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?
- Of its descendants, K981343 (Ercons, Inc., 1998) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LKY devicesLKY Device, External Penile Rigidity: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LKY
FDA has decided no LKY device since 2007.
Median 510(k) review, days · LKY
Too few LKY 510(k)s in any year since 2007 to give a median.
Recalls per year · LKY
No recall names LKY since 2007.
Adverse event reports per year · LKY
2in 2023
MAUDE reports naming product code LKY, 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 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K891125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K891125: Constrictor Ring for Penile Erection.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K891125
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026