510(k) · Cleared
ClearedGuardian Urethral Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solace Therapeutics · KNY Accessories, Catheter, G-U
Cleared on Aug 20, 2013 as substantially equivalent to K052298 (Percutaneous Systems, Incorporated, 2006) after a 62-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Aug 20, 2013
- Review
- 62 days
- Class
- Class II
- Product code
- KNY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052298 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK052298 Cystoglide Introducer SheathPercutaneous Systems, Incorporated · 2006
- This deviceK131803 Guardian Urethral SheathSolace Therapeutics · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052298 | Cystoglide Introducer Sheath | Percutaneous Systems, Incorporated | 2006 | — |
| 0 (this device) | K131803 | Guardian Urethral Sheath | Solace Therapeutics | 2013 | — |
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 KNY? 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 KNY device
- #1 K260919 Transurethral Catheter Safety Valve (TUCSV)…score 11.8 · 1 generation · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052298 | Cystoglide Introducer SheathSummary page 1…me: Urological catheter Class: 11 Classification Name: Urological catheter (21 CER 876.5130, Product Code KNY) 3. Predicate Devices Guardian Urethral Sheath K052298 (formerly CYSTOGLIDE INTRODUCER SF1EATH) 4. Device Description The Solace Guardian Urethral Sheath is an eventing sleeve s… | 2006 |
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 KNY devicesKNY Accessories, Catheter, G-U: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · KNY
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · KNY
103in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNY
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNY
3in 2025
MAUDE reports naming product code KNY, 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 | 0 | — | 0 | 15 |
| 2008 | 0 | — | 0 | 19 |
| 2009 | 1 | — | 0 | 10 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 1 | — | 1 | 6 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 3 | 103 | 0 | 7 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 19 |
| 2017 | 1 | — | 0 | 21 |
| 2018 | 1 | — | 0 | 17 |
| 2019 | 0 | — | 0 | 19 |
| 2020 | 0 | — | 0 | 36 |
| 2021 | 0 | — | 0 | 17 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 0 | — | 1 | 5 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Guardian Urethral Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The Guardian Urethral Sheath is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131803 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131803: Guardian Urethral Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131803
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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