510(k) · Cleared
ClearedFirlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · GBM Catheter, Urethral
Cleared on Nov 22, 2017 as substantially equivalent to K820313 (Vance Products, Inc., 1982) and 1 other predicate after a 117-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Nov 22, 2017
- Review
- 117 days
- Class
- Class II
- Product code
- GBM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K896053 (1990). 4 ancestors in all, the oldest K820313 (1982). No later device cites it as a predicate yet.
- Root · 3 generations backK896053 All Silicone Foley CatheterRochester Medical Corp. · 1990
- 2 generations backK981612 All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley…Rochester Medical Corp. · 1998
- 1 generation backK130908 Disposable Silicone Foley CatheterGuangdong Baihe Medical Technology Co., Ltd. · 2013
- This deviceK172278 Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral StentCook Incorporated · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K896053 | All Silicone Foley Catheter | Rochester Medical Corp. | 1990 | — |
| −2 | K981612 | All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter… | Rochester Medical Corp. | 1998 | — |
| −1 | K130908 | Disposable Silicone Foley Catheter | Guangdong Baihe Medical Technology Co., Ltd. | 2013 | — |
| 0 (this device) | K172278 | Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent | Cook Incorporated | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
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 K241734 Wellead® Hydrophilic Intermittent Catheter…score 10.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K820313 | Vpi-Fair Urethral StentSummary page 7…Device Class/Classification Panel: Class II, Gastroenterology/Urology Predicate Device: The predicate devices are the VPI-Fair Urethral Stent cleared under 510(k) K820313 and the Disposable Silicone Foley Catheter cleared under K130908. Device Description: The Firlit-Kluge Urethral Stent is cons… | 1982 |
| * | K130908 | Disposable Silicone Foley CatheterSummary page 7…/Urology Predicate Device: The predicate devices are the VPI-Fair Urethral Stent cleared under 510(k) K820313 and the Disposable Silicone Foley Catheter cleared under K130908. Device Description: The Firlit-Kluge Urethral Stent is constructed out of silicone tubing and a silicone ball. The stent tub… | 2013 |
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 27 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All GBM devicesGBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · GBM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GBM
230in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GBM
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GBM
311in 2025
MAUDE reports naming product code GBM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 5 |
| 2008 | 0 | — | 5 | 18 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 33 |
| 2011 | 2 | — | 1 | 46 |
| 2012 | 3 | 139 | 0 | 32 |
| 2013 | 0 | — | 0 | 41 |
| 2014 | 1 | — | 0 | 19 |
| 2015 | 5 | 76 | 0 | 21 |
| 2016 | 3 | 112 | 0 | 49 |
| 2017 | 2 | — | 0 | 59 |
| 2018 | 6 | 93 | 0 | 82 |
| 2019 | 7 | 121 | 0 | 148 |
| 2020 | 6 | 230 | 0 | 144 |
| 2021 | 0 | — | 0 | 102 |
| 2022 | 2 | — | 0 | 283 |
| 2023 | 0 | — | 1 (1) | 202 |
| 2024 | 0 | — | 0 | 468 |
| 2025 | 1 | — | 1 | 311 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
This device is used for stenting the urethra during hypospadias or epispadias repair and to allow postoperative drainage of the bladder in infants (29 days to less than 2 years old) and children (2 years old to less than 12 years old).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172278: Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172278
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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