510(k) · Cleared
ClearedErco-Vac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ercons, Inc. · LKY Device, External Penile Rigidity
Cleared on Nov 3, 1997 as substantially equivalent to K841257 (Nu-Potent, 1984) and 3 other predicates after a 118-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Nov 3, 1997
- Review
- 118 days
- Class
- Class II
- Product code
- LKY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K841257 (1984). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK841257 Sta-Potent SystemNu-Potent · 1984
- This deviceK972537 Erco-VacErcons, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K841257 | Sta-Potent System | Nu-Potent | 1984 | — |
| 0 (this device) | K972537 | Erco-Vac | Ercons, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1996 | 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 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? (4)
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 |
|---|---|---|---|
| * | K841257 | Sta-Potent SystemSummary page 1…Ltd. 2. VED Mission Pharmacal Co. 3. Pos-T-Vac POS-T-VAC Code of Federal Regulation (CFR) Number: Product Code: SECTION 5§14 SPECIAL CONTROLS evsum31o NOV - 3 1997 K841257 K901223 K960828, K960342 Unclassified 78 LKY KA72537 (1 <) Special Controls under Section 514 of the Act have not been deve… | 1984 |
| * | K901223 | Vacuum Erection Device (Ved)Summary page 1…VED Mission Pharmacal Co. 3. Pos-T-Vac POS-T-VAC Code of Federal Regulation (CFR) Number: Product Code: SECTION 5§14 SPECIAL CONTROLS evsum31o NOV - 3 1997 K841257 K901223 K960828, K960342 Unclassified 78 LKY KA72537 (1 <) Special Controls under Section 514 of the Act have not been developed for… | 1990 |
| * | K960828 | Pos-T-Vac B-10 Band KitSummary page 1…on Pharmacal Co. 3. Pos-T-Vac POS-T-VAC Code of Federal Regulation (CFR) Number: Product Code: SECTION 5§14 SPECIAL CONTROLS evsum31o NOV - 3 1997 K841257 K901223 K960828, K960342 Unclassified 78 LKY KA72537 (1 <) Special Controls under Section 514 of the Act have not been developed for these de… | 1996 |
| * | K960342 | Pos-T-Vac Avp-1000 & MVP-700Summary page 1…cal Co. 3. Pos-T-Vac POS-T-VAC Code of Federal Regulation (CFR) Number: Product Code: SECTION 5§14 SPECIAL CONTROLS evsum31o NOV - 3 1997 K841257 K901223 K960828, K960342 Unclassified 78 LKY KA72537 (1 <) Special Controls under Section 514 of the Act have not been developed for these devices. Re… | 1996 |
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?
- None of the 4 ancestors has a recall.
- 7 other devices also cite its predicate K841257.
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?
Erco-Vac™ is used to maintain penile rigidity in men with erectile dysfunction . Erco-Vac™ can be used for patients with following conditions:
Diabetes
Venous leakage
Prostatectomy
Hypertension
Psychogenic condition
Impotence due to radiation therapy
Spinal cord injury
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/K972537 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972537: Erco-Vac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972537
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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