510(k) · Cleared
ClearedPos-T-Vac Avp-1000 & MVP-700
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pos-T-Vac, Inc. · LKY Device, External Penile Rigidity
Cleared on Mar 1, 1996 after a 37-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Mar 1, 1996
- Review
- 37 days
- Class
- Class II
- Product code
- LKY
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK960342 Pos-T-Vac Avp-1000 & MVP-700Pos-T-Vac, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK981357 Erco-VacErcons, Inc. · 1998
- Descendant · 2 generations on · 0 of its ownK990006 Erco-Vac -CErcons, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK972537 Erco-VacErcons, Inc. · 1997
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960342 | Pos-T-Vac Avp-1000 & MVP-700 | Pos-T-Vac, Inc. | 1996 | — |
| +1 | K981357 | Erco-Vac | Ercons, Inc. | 1998 | — |
| +2 | K990006 | Erco-Vac -C | Ercons, Inc. | 1999 | — |
| +1 | K972537 | Erco-Vac | Ercons, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
2 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, K981357 (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/K960342 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960342: Pos-T-Vac Avp-1000 & MVP-700.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960342
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026