510(k) · Cleared

Cleared

Erco-Vac

K981357510(k) TraditionalCleared Nov 24, 1998224-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

Ercons, Inc. · LKY Device, External Penile Rigidity

Cleared on Nov 24, 1998 as substantially equivalent to K841257 (Nu-Potent, 1984) and 3 other predicates after a 224-day review. Its family tree reaches back 1 generation to 1984. 1 later device descends from it.

Decided: Nov 24, 1998
Review: 224 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. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK841257 Sta-Potent SystemNu-Potent · 1984
This deviceK981357 Erco-VacErcons, Inc. · 1998
Descendant · cites it directly · 0 of its ownK990006 Erco-Vac -CErcons, Inc. · 1999

Most influential descendants

Showing 1 of 1 · See all

K990006Erco-Vac -CErcons, Inc. · 1999 · cites it directly0descendants

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)	K981357	Erco-Vac	Ercons, Inc.	1998	—
+1	K990006	Erco-Vac -C	Ercons, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1996	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K981357, 1984–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K841257	Sta-Potent System Summary page 1 …ice President Date: April 7, 1998 Trade name - Erco-Vac'M Common name -external penile rigidity device Equivalence is claimed to: 1. Erercaid Osbon Medical Systems, Ltd. K841257 2. VED Mission Pharmacal Co. K901223 3. Pos-T-Vac POS-T-VAC K960828, K960342 Code of Federal Regulation (CFR) Number: Unclassifie…	Nu-Potent	1984	—
*	K901223	Vacuum Erection Device (Ved) Summary page 1 …de name - Erco-Vac'M Common name -external penile rigidity device Equivalence is claimed to: 1. Erercaid Osbon Medical Systems, Ltd. K841257 2. VED Mission Pharmacal Co. K901223 3. Pos-T-Vac POS-T-VAC K960828, K960342 Code of Federal Regulation (CFR) Number: Unclassified Product Code: 78 LKY SECTION 514 S…	Mission Pharmacal Co.	1990	—
*	K960828	Pos-T-Vac B-10 Band Kit Summary page 1 …e -external penile rigidity device Equivalence is claimed to: 1. Erercaid Osbon Medical Systems, Ltd. K841257 2. VED Mission Pharmacal Co. K901223 3. Pos-T-Vac POS-T-VAC K960828, K960342 Code of Federal Regulation (CFR) Number: Unclassified Product Code: 78 LKY SECTION 514 SPECIAL CONTROLS Special Contro…	Pos-T-Vac, Inc.	1996	—
*	K960342	Pos-T-Vac Avp-1000 & MVP-700 Summary page 1 …al penile rigidity device Equivalence is claimed to: 1. Erercaid Osbon Medical Systems, Ltd. K841257 2. VED Mission Pharmacal Co. K901223 3. Pos-T-Vac POS-T-VAC K960828, K960342 Code of Federal Regulation (CFR) Number: Unclassified Product Code: 78 LKY SECTION 514 SPECIAL CONTROLS Special Controls under…	Pos-T-Vac, Inc.	1996	—

Also cleared against K841257: 7 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K990006	Erco-Vac -C	Ercons, Inc.	1999	0

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.
Of its descendants, K990006 (Ercons, Inc., 1999) has gone furthest, with 0 descendants of its own.
7 other devices also cite its predicate K841257.

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

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

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	1
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	1
2014	—	1
2015	—	0
2016	—	1
2017	—	2
2018	—	3
2019	—	0
2020	—	0
2021	—	0
2022	—	1
2023	—	2
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

Erco-Vac M is used to create an erection in men with erectile dysfunction.

Erco-Vac M can be used for patients with following conditions:

Diabetes

Venous leakage

Prostatectomy

Hypertension

Psychogenic impotence

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/K981357 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981357: Erco-Vac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981357

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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