510(k) · Cleared

Cleared

Erco-Ribbon

K981343510(k) TraditionalCleared Nov 24, 1998225-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 225-day review. Its family tree reaches back 1 generation to 1984. 1 later device descends from it.

Decided: Nov 24, 1998
Review: 225 days
Class: Class II
Product code: LKY
Recalls: None
Predicates: 6

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 deviceK981343 Erco-RibbonErcons, Inc. · 1998
Descendant · cites it directly · 0 of its ownK990008 Erco-Ribbon -CErcons, Inc. · 1999

Most influential descendants

Showing 1 of 1 · See all

K990008Erco-Ribbon -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)	K981343	Erco-Ribbon	Ercons, Inc.	1998	—
+1	K990008	Erco-Ribbon -C	Ercons, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1990	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K981343, 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? (6)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K841257	Sta-Potent System Summary page 1 …, 1998 Trade name - Erco-Ribbon ™ Common name - constriction device for external penile rigidity system Equivalence is claimed to: ErecAid Osbon Medical Systems, Ltd. K841257 Revive Revive System Corp. KB844445 Confidence Performance, Inc. K891125 VED Mission Pharmacal Co. KS01223 VET VET-CO, Inc. K9022…	Nu-Potent	1984	—
Kept off the family tree	K884445	FDA’s K884445 is Maxithins Panty Shields, Deodorant Our OCR of the scanned summary read K884445, FDA’s number for Maxithins Panty Shields, Deodorant (Tambrands, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Revive”. Kept off the family tree.	Tambrands, Inc.	1988	—
*	K891125	Constrictor Ring for Penile Erection Summary page 1 …external penile rigidity system Equivalence is claimed to: ErecAid Osbon Medical Systems, Ltd. K841257 Revive Revive System Corp. KB844445 Confidence Performance, Inc. K891125 VED Mission Pharmacal Co. KS01223 VET VET-CO, Inc. K9022403. Pos-T-Vac POS-T-VAC K960828 Code of Federal Regulation (CFR) Number:…	Performance, Inc.	1989	—
*	K901223	Vacuum Erection Device (Ved) Our OCR of the scanned summary read K501223, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “VED”.	Mission Pharmacal Co.	1990	—
Kept off the family tree	K902403	FDA’s K902403 is Elite R/F Spot Film Drive Our OCR of the scanned summary read K902403, FDA’s number for Elite R/F Spot Film Drive (Rms Div.). Its FDA name has none of the distinctive words the summary uses for the device it names, “VET”. Kept off the family tree.	Rms Div.	1990	—
*	K960828	Pos-T-Vac B-10 Band Kit Summary page 1 …s, Ltd. K841257 Revive Revive System Corp. KB844445 Confidence Performance, Inc. K891125 VED Mission Pharmacal Co. KS01223 VET VET-CO, Inc. K9022403. Pos-T-Vac POS-T-VAC K960828 Code of Federal Regulation (CFR) Number: Unclassified Product Code: 78 LKY Ercons, Inc. PATENT PENDING Erco-Ribbon™ GON=RENTM\|.…	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
K990008	Erco-Ribbon -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, K990008 (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-Ribbon ™ is used to maintain penile rigidity in men with erectile dysfunction. It restricts blood outflow from the penis after the patient has obtained an erection (either with the aid of a vacuum pump, or naturally). Men with firm but short lasting erection may use constricting device separately. If a man is impotent to a degree that he is unable to achieve a natural erection, a vacuum constriction system may help him to overcome this dysfunction.…

Read the full statement (120 words)

Men with firm but short lasting erection may use constricting device separately.

If a man is impotent to a degree that he is unable to achieve a natural erection, a vacuum constriction system may help him to overcome this dysfunction.

Erco-Ribbon ™ can be used for patients with following conditions:

a) separately:

premature ejaculation,

firm but short lasting erection.

b) as a part of a vacuum constriction system:

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/K981343 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981343: Erco-Ribbon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981343

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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