510(k) Report

510(k) · Cleared

Cleared

Pediatric Urinary Catheter

K060268510(k) TraditionalCleared Feb 24, 200623-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

Clay Kennard · GBM Catheter, Urethral

Cleared on Feb 24, 2006 as substantially equivalent to K031409 (Promedic, Inc., 2003) after a 23-day review. Its family tree reaches back 1 generation to 2003.

Decided
Feb 24, 2006
Review
23 days
Class
Class II
Product code
GBM
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K031409 (2003). No later device cites it as a predicate yet.

K031409 · Urinary Catheters · Promedic, Inc. · 200320002002200420062008
K031409 · Urinary Catheters · Promedic, Inc. · 20030
  1. Root · 1 generation backK031409 Urinary CathetersPromedic, Inc. · 2003
  2. This deviceK060268 Pediatric Urinary CatheterClay Kennard · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K031409Urinary CathetersPromedic, Inc.2003—
0 (this device)K060268Pediatric Urinary CatheterClay Kennard2006—
FIG. 1 — Lineage of K060268, 2003–2006Source: 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 GBM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GBM device

  1. #1 K241734 Wellead® Hydrophilic Intermittent Catheter…score 10.2 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

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
*K031409Urinary Catheters
Summary page 1
…Urinary catheter Classification Name: Catheter, urethral (and Accessories) Predicate Devices: ProMedic K03 1409 Device Description: The silicone pediatric urinary catheter is a small diameter tube of various diameters, 3.5, 5.0, 6.5, and…
Promedic, Inc.2003—

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?

  • Its one ancestor has no recall.

How does its category compare?

All GBM devices

GBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GBM

1in 2025

2007: 22009: 12011: 22012: 32014: 12015: 52016: 32017: 22018: 62019: 72020: 62022: 22025: 1
2007high 7 (2019) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GBM

230in 2020

2012: 139 days median2015: 76 days median2016: 112 days median2018: 93 days median2019: 121 days median2020: 230 days median
2007high 230 (2020) · low 76 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GBM

1in 2025

2008: 52011: 12023: 1, 1 Class I2025: 12026 (partial year): 1
2007high 5 (2008) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GBM

311in 2025

2007: 52008: 182009: 32010: 332011: 462012: 322013: 412014: 192015: 212016: 492017: 592018: 822019: 1482020: 1442021: 1022022: 2832023: 2022024: 4682025: 311
2007high 468 (2024) · low 3 (2009)2025

MAUDE reports naming product code GBM, 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
20072—05
20080—518
20091—03
20100—033
20112—146
20123139032
20130—041
20141—019
2015576021
20163112049
20172—059
2018693082
201971210148
202062300144
20210—0102
20222—0283
20230—1 (1)202
20240—0468
20251—1311
20260—1—

What is it indicated for?

The urinary catheter is for use with patients requiring urine drainage, with chronic urine retention and with post-void residual volume (PVR). The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

Indications for use as stated in the FDA summary.

Recent decisions in GBM

The GBM category page

  • K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd. · 2025
  • K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec Limited · 2022
  • K211436Intermittent Catheter (Not Finalized)Hollister Incorporated · 20221 recall
  • K200820SpeediCath Compact SetColoplast · 2020
  • K192904SpeediCath Compact SetColoplast · 2020

https://510kreport.com/device/K060268 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060268: Pediatric Urinary Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060268

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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