510(k) Report

510(k) · Cleared

Cleared

Pos-T-Vac B-10 Band Kit

K960828510(k) TraditionalCleared Mar 8, 19968-day reviewClass II21 CFR 876.5020

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pos-T-Vac, Inc. · LKY Device, External Penile Rigidity

Cleared on Mar 8, 1996 after an 8-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.

Decided
Mar 8, 1996
Review
8 days
Class
Class II
Product code
LKY
Recalls
None
Predicates
0

6 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 1999: 2 descendants cleared1998: 2 descendants cleared1997: 2 descendants cleared1995200020052010201520202025
  1. This deviceK960828 Pos-T-Vac B-10 Band KitPos-T-Vac, Inc. · 1996
  2. Descendant · cites it directly · 1 of its ownK981357 Erco-VacErcons, Inc. · 1998
  3. Descendant · cites it directly · 1 of its ownK981343 Erco-RibbonErcons, Inc. · 1998
  4. Descendant · cites it directly · 0 of its ownK990006 Erco-Vac -CErcons, Inc. · 1999
  5. Descendant · cites it directly · 0 of its ownK990008 Erco-Ribbon -CErcons, Inc. · 1999
  6. Descendant · cites it directly · 0 of its ownK972537 Erco-VacErcons, Inc. · 1997

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1997: 21998: 21999: 2
1997high 2 (1997) · low 0 (2000)2026

Most influential descendants

Showing 5 of 6 · See all
  • K981357Erco-VacErcons, Inc. · 1998 · cites it directly1descendant
  • K981343Erco-RibbonErcons, Inc. · 1998 · cites it directly1descendant
  • K990006Erco-Vac -CErcons, Inc. · 1999 · cites it directly0descendants
  • K990008Erco-Ribbon -CErcons, Inc. · 1999 · cites it directly0descendants
  • K972537Erco-VacErcons, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K960828Pos-T-Vac B-10 Band KitPos-T-Vac, Inc.1996—
+1K981357Erco-VacErcons, Inc.1998—
+1K981343Erco-RibbonErcons, Inc.1998—
+1K990006Erco-Vac -CErcons, Inc.1999—
+1K990008Erco-Ribbon -CErcons, Inc.1999—
+1K972537Erco-VacErcons, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199820
199920
FIG. 1 — Lineage of K960828, 1996–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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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? (6)

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K981357Erco-VacErcons, Inc.19981
K981343Erco-RibbonErcons, Inc.19981
K990006Erco-Vac -CErcons, Inc.19990
K990008Erco-Ribbon -CErcons, Inc.19990
K972537Erco-VacErcons, Inc.19970
K972353Erco-RibbonErcons, Inc.19970

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 devices

LKY 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

2008: 12013: 12014: 12016: 12017: 22018: 32022: 12023: 2
2007high 3 (2018) · low 0 (2007)2025

MAUDE reports naming product code LKY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—01
20090—00
20100—00
20110—00
20120—00
20130—01
20140—01
20150—00
20160—01
20170—02
20180—03
20190—00
20200—00
20210—00
20220—01
20230—02
20240—00
20250—00
20260—0—

More from Pos-T-Vac, Inc.

12 FDA decisions under this applicant name. See the company

  • K020258Support SleevePos-T-Vac, Inc. · 2002
  • K020154VT-1Pos-T-Vac, Inc. · 2002
  • K012670Boss 2000-3 Vacuum Erection DevicePos-T-Vac, Inc. · 2001
  • K012672Boss-2000-2 Vacuum Erection DevicePos-T-Vac, Inc. · 2001
  • K983246Pos-T-Vac (Ivp-600)Pos-T-Vac, Inc. · 1998

Recent decisions in LKY

The LKY category page

  • K041573Nanma Vacuum Pump Proxzek Model 2M9498SNanma Mfg Co., Ltd. · 2004
  • K032776Vacurect Vacuum Constriction DeviceVacurect Manufacturing (Pty), Ltd. · 2003
  • K030119Nanma Adjustable Constriction RingNanma Mfg Co., Ltd. · 2003
  • K030913Nanma Vacuum PumpNanma Mfg Co., Ltd. · 2003
  • K013113Modification to Nanma Vacuum PumpNanma Mfg Co., Ltd. · 2002

https://510kreport.com/device/K960828 · printed Nov 5, 2026

Cite this page

510(k) Report. “K960828: Pos-T-Vac B-10 Band Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960828

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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