510(k) Report

510(k) · Cleared

Cleared

Erco-Ribbon

K972353510(k) TraditionalCleared Oct 28, 1997126-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 Oct 28, 1997 as substantially equivalent to K841257 (Nu-Potent, 1984) and 5 other predicates after a 126-day review. Its family tree reaches back 1 generation to 1984.

Decided
Oct 28, 1997
Review
126 days
Class
Class II
Product code
LKY
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K841257 (1984). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestor1990: 2 other ancestors1989: 1 other ancestor1985: 1 other ancestorK841257 · Sta-Potent System · Nu-Potent · 19841980198519901995
Other ancestors, by generation 1 generation back: 5 other ancestors K841257 · Sta-Potent System · Nu-Potent · 19840
  1. Root · 1 generation backK841257 Sta-Potent SystemNu-Potent · 1984
  2. This deviceK972353 Erco-RibbonErcons, Inc. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K841257Sta-Potent SystemNu-Potent1984—
0 (this device)K972353Erco-RibbonErcons, Inc.1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198910
199020
199610
FIG. 1 — Lineage of K972353, 1984–1997Source: 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), 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
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K841257Sta-Potent System
Summary page 1
…1997 Trade name - Erco-Ribbon™ Common name - constriction device for extemal penile rigidity system Equivalence is claimed to: 1. ErecAid Osbon Medical Systems, Ltd. K841257 2. Revive Revive System Corp. K844445 3. Confidence Performance, Inc. K891125 4. VED Mission Pharmacal Co. K901223 5. VET VET…
Nu-Potent1984—
*K844445Revive System
Summary page 1
…name - constriction device for extemal penile rigidity system Equivalence is claimed to: 1. ErecAid Osbon Medical Systems, Ltd. K841257 2. Revive Revive System Corp. K844445 3. Confidence Performance, Inc. K891125 4. VED Mission Pharmacal Co. K901223 5. VET VET-CO, Inc. K902240 3. Pos-T-Vac POS-T-V…
Revive Systems Corp.1985—
*K891125Constrictor Ring for Penile Erection
Summary page 1
…enile rigidity system Equivalence is claimed to: 1. ErecAid Osbon Medical Systems, Ltd. K841257 2. Revive Revive System Corp. K844445 3. Confidence Performance, Inc. K891125 4. VED Mission Pharmacal Co. K901223 5. VET VET-CO, Inc. K902240 3. Pos-T-Vac POS-T-VAC K960828 Code of Federal Regulation (C…
Performance, Inc.1989—
*K901223Vacuum Erection Device (Ved)
Summary page 1
…claimed to: 1. ErecAid Osbon Medical Systems, Ltd. K841257 2. Revive Revive System Corp. K844445 3. Confidence Performance, Inc. K891125 4. VED Mission Pharmacal Co. K901223 5. VET VET-CO, Inc. K902240 3. Pos-T-Vac POS-T-VAC K960828 Code of Federal Regulation (CFR) Number: Unclassified Product Code…
Mission Pharmacal Co.1990—
*K902240Vet (Vacuum Erection Technology)
Summary page 1
…Medical Systems, Ltd. K841257 2. Revive Revive System Corp. K844445 3. Confidence Performance, Inc. K891125 4. VED Mission Pharmacal Co. K901223 5. VET VET-CO, Inc. K902240 3. Pos-T-Vac POS-T-VAC K960828 Code of Federal Regulation (CFR) Number: Unclassified Product Code: 78 LKY Ercons, Inc. PATENT…
Vetco, Inc.1990—
*K960828Pos-T-Vac B-10 Band Kit
Summary page 1
…2. Revive Revive System Corp. K844445 3. Confidence Performance, Inc. K891125 4. VED Mission Pharmacal Co. K901223 5. VET VET-CO, Inc. K902240 3. Pos-T-Vac POS-T-VAC K960828 Code of Federal Regulation (CFR) Number: Unclassified Product Code: 78 LKY Ercons, Inc. PATENT PENDING Erco-Ribbon™ CONFIDENTI…
Pos-T-Vac, Inc.1996—

Also cleared against K841257: 7 other devices →

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 6 ancestors has a recall.
  • 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

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—

What is it indicated for?

Erco-Ribbon™ is used to maintain penile rigidity in men with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection (either with the aid of a vacuum pump or naturally).

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 condition

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.

Also cleared against K841257

7 other devices cite the same predicate.

  • K990008Erco-Ribbon -CErcons, Inc. · 1999
  • K990006Erco-Vac -CErcons, Inc. · 1999
  • K981357Erco-VacErcons, Inc. · 1998
  • K981343Erco-RibbonErcons, Inc. · 1998
  • K981506Restore Vacuum Erection Device, Confide Vacuum Erection Device, Pep (Penile Erection Program), Rely Vacuum…Repro-Med Systems, Inc. · 1998
  • K974173Erecaid System/Stay Erec SystemImagyn Medical Technologies, Inc. · 1998

More from Ercons, Inc.

6 FDA decisions under this applicant name. See the company

  • K990006Erco-Vac -CErcons, Inc. · 1999
  • K990008Erco-Ribbon -CErcons, Inc. · 1999
  • K981357Erco-VacErcons, Inc. · 1998
  • K981343Erco-RibbonErcons, Inc. · 1998
  • K972537Erco-VacErcons, Inc. · 1997

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/K972353 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972353: 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/K972353

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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