510(k) · Cleared
ClearedErecxel Adjustable Penile Bands, Contrex Adjustable Penile Bands
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erecxel Enterprises · LKY Device, External Penile Rigidity
Cleared on Mar 20, 2000 as substantially equivalent to K981180 (Pos-T-Vac, Inc., 1998) after a 167-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Mar 20, 2000
- Review
- 167 days
- Class
- Class II
- Product code
- LKY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981180 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK981180 Rejoyn Constriction Ring Kit, Pos-T-Vac B-100 Ring Kit, Pos-T-Vac…Pos-T-Vac, Inc. · 1998
- This deviceK993343 Erecxel Adjustable Penile Bands, Contrex Adjustable Penile BandsErecxel Enterprises · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981180 | Rejoyn Constriction Ring Kit, Pos-T-Vac B-100 Ring Kit, Pos-T-Vac B-25 Ring… | Pos-T-Vac, Inc. | 1998 | — |
| 0 (this device) | K993343 | Erecxel Adjustable Penile Bands, Contrex Adjustable Penile Bands | Erecxel Enterprises | 2000 | — |
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 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? (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 |
|---|---|---|---|
| * | K981180 | Rejoyn Constriction Ring Kit, Pos-T-Vac B-100 Ring Kit, Pos-T-Vac B-25 Ring Kit and…Summary page 1…999 Trade Name: ERECXEL Adjustable Penile Bands Common Name: External Device for Penile Rigidity Equivalence is claimed to: REJOYN Constriction Rings POST-T-VAC, Inc. K981180 CFR Number: Unclassified Product Code: 78 LKY Description of the Device: ERECXEL Adjustable Penile Band is an external penile c… | 1998 |
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?
- Its one ancestor has no recall.
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 | — |
What is it indicated for?
The ERECXEL Adjustable Penile Bands are indicated as over-the-counter treatment
for men with erection problem due to penile venous leakage. During erection, the
ERECXEL Adjustable Penile Bands device helps to produce penile rigidity by
constricting the penile veins around the base of the penis to restrict the flow of blood
from leaving the penis.
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/K993343 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993343: Erecxel Adjustable Penile Bands, Contrex Adjustable Penile Bands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993343
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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