# K981343: Erco-Ribbon

- Pathway: 510(k) (Traditional)
- Applicant: Ercons, Inc.
- Decided: Nov 24, 1998 after 225 days
- Product code: LKY (Device, External Penile Rigidity)
- Device class: 2
- Regulation: 21 CFR 876.5020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K841257 (1984). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K841257: Sta-Potent System, Nu-Potent (1984) Summary page 1.
- K891125: Constrictor Ring for Penile Erection, Performance, Inc. (1989) Summary page 1.
- K901223: Vacuum Erection Device (Ved), Mission Pharmacal Co. (1990). 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”.
- K960828: Pos-T-Vac B-10 Band Kit, Pos-T-Vac, Inc. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K884445: Maxithins Panty Shields, Deodorant, Tambrands, Inc. (1988). 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.
- K902403: Elite R/F Spot Film Drive, Rms Div. (1990). 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.

## Most influential descendants
- K990008: Erco-Ribbon -C (1999), 0 descendants of its own

## Indications for use
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. 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

Source page: https://510kreport.com/device/K981343
Methodology: https://510kreport.com/methodology