510(k) Report

510(k) · Cleared

Cleared

Conveen (R) Urisheath and Uriliner (Male Exter Cath)

K915246510(k) TraditionalCleared Feb 5, 199282-day reviewClass I21 CFR 876.5250

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

Coloplast A/S · EXI Device, Paste-On For Incontinence, Sterile

Cleared on Feb 5, 1992 after an 82-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Feb 5, 1992
Review
82 days
Class
Class I
Product code
EXI
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K915246Source: FDA 510(k) database · 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.

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  • 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?

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.

How does its category compare?

All EXI devices

EXI Device, Paste-On For Incontinence, Sterile: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EXI

FDA has decided no EXI device since 2007.

Median 510(k) review, days · EXI

Too few EXI 510(k)s in any year since 2007 to give a median.

Recalls per year · EXI

No recall names EXI since 2007.

Adverse event reports per year · EXI

1in 2020

2011: 12020: 1
2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code EXI, 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—00
20090—00
20100—00
20110—01
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—01
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Coloplast A/S

71 FDA decisions under this applicant name. See the company

  • K221874Altis Single Incision Sling SystemColoplast A/S · 2023
  • K220420Saffron Fixation SystemColoplast A/S · 2022
  • K191536Biatain Silicone AgColoplast A/S · 2020
  • K181811ReTrace Ureteral Access SheathColoplast A/S · 2018
  • K173527Digitex Delivery DeviceColoplast A/S · 2018

Recent decisions in EXI

The EXI category page

  • K971499Female External Urinary Collection PouchMediquest, Inc. · 1997
  • K970443Hollister Retracted Penis PouchHollister, Inc. · 1997
  • K963950Bioderm Eid Male External Incontinence DeviceBioderm, Inc. · 1997
  • K931277Hollister Premium Urine CollectorHollister, Inc. · 1993
  • K924755Convatec Little Ones Pediatric Urine CollectionConvatec, A Division of E.R. Squibb & Sons · 1993

https://510kreport.com/device/K915246 · printed Nov 6, 2026

Cite this page

510(k) Report. “K915246: Conveen (R) Urisheath and Uriliner (Male Exter Cath).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915246

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026