510(k) Report

510(k) · Cleared

Cleared

Dfiner Urological Catheter

K013360510(k) TraditionalCleared Feb 20, 2002133-day reviewClass II21 CFR 876.5130

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

Neoseed Technology,Llc · FGI Catheter, Urethrographic, Male

Cleared on Feb 20, 2002 as substantially equivalent to K965229 (Boston Scientific Corp, 1997) and 1 other predicate after a 133-day review. Its family tree reaches back 2 generations to 1997.

Decided
Feb 20, 2002
Review
133 days
Class
Class II
Product code
FGI
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K965229 (1997). No later device cites it as a predicate yet.

K965229 · Imager Torque Catheter · Boston Scientific Corp · 1997K011965 · Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1 · Boston Scientific Corp · 2001 · recalled19961998200020022004
K011965 · Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1 · Boston Scientific Corp · 2001 · recalledK965229 · Imager Torque Catheter · Boston Scientific Corp · 19970
  1. Root · 2 generations backK965229 Imager Torque CatheterBoston Scientific Corp · 1997
  2. 1 generation backK011965 Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1Boston Scientific Corp · 2001 · Recalled
  3. This deviceK013360 Dfiner Urological CatheterNeoseed Technology,Llc · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K965229Imager Torque CatheterBoston Scientific Corp1997—
−1K011965Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1Boston Scientific Corp20012
0 (this device)K013360Dfiner Urological CatheterNeoseed Technology,Llc2002—
FIG. 1 — Lineage of K013360, 1997–2002Source: 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.

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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? (2)

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
*K965229Imager Torque Catheter
Summary page 1
…iner Urological Catheter Common Name: Male Urethrographic Catheter Classification Name: Urological Catheter and Accessories D. Predicate Devices Imager Torque Catheter, K965229 Imager II Torque Catheter, KO11965 E. Description of Device The Dfiner Urological Catheter is a dual lumen flexible co-axial cat…
Boston Scientific Corp1997—
*K011965Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1Boston Scientific Corp20012

Also cleared against K965229: 1 other device →

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?

  • The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • 1 other device also cites its predicate K965229.

How does its category compare?

All FGI devices

FGI Catheter, Urethrographic, Male: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FGI

FDA has decided no FGI device since 2007.

Median 510(k) review, days · FGI

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

Recalls per year · FGI

No recall names FGI since 2007.

Adverse event reports per year · FGI

No MAUDE report names FGI since 2007.

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—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Dfiner is indicated for catheterization of the male urethra for the introduction of contrast materials.

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 K965229

1 other device cites the same predicate.

  • K011965Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1Boston Scientific Corp · 20012 recalls

Recent decisions in FGI

The FGI category page

  • K023019Vomed Urethra Olive, Models 1420 000, 1425 000, 1430 000Vomed Volzer Medizintechnik GmbH & Co. · 2002
  • K810370Pollack Chain Cysourethrogram SetVance Products, Inc. · 1981

https://510kreport.com/device/K013360 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013360: Dfiner Urological Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013360

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026