510(k) · Cleared
ClearedAmsure Bladder Irrigation Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amsino Intl., Inc. · LJH System, Irrigation, Urological
Cleared on Dec 19, 2007 as substantially equivalent to K970946 (Medline Industries, Inc., 1997) after a 265-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Dec 19, 2007
- Review
- 265 days
- Class
- Class II
- Product code
- LJH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K934382 (1994). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 LJH? 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 LJH device
- #1 K254111 Irrigation/Urology Setsscore 12.0 · 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 |
|---|---|---|---|
| * | K970946 | Medline Y-Type Tur/Bladder Irrigation SetSummary page 1…LJH Medical Specialty: Gastroenterology/Urology Device Class: Unclassified (51 OK) Predicate Devices: Medline Y-Type TUR/Bladder Irrigation Set (K970946) Device Description: The AMSure " Bladder Irrigation Set is comprised of tubing with a… | 1997 |
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 13 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All LJH devicesLJH System, Irrigation, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LJH
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · LJH
77in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJH
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LJH
25in 2025
MAUDE reports naming product code LJH, 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 | 3 | 77 | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 30 |
| 2011 | 0 | — | 0 | 27 |
| 2012 | 0 | — | 0 | 22 |
| 2013 | 0 | — | 0 | 44 |
| 2014 | 0 | — | 0 | 97 |
| 2015 | 0 | — | 0 | 642 |
| 2016 | 0 | — | 0 | 32 |
| 2017 | 1 | — | 0 | 19 |
| 2018 | 0 | — | 0 | 18 |
| 2019 | 0 | — | 0 | 16 |
| 2020 | 0 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 0 | — | 1 | 21 |
| 2023 | 0 | — | 0 | 34 |
| 2024 | 0 | — | 0 | 13 |
| 2025 | 0 | — | 0 | 25 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The AMSure® Bladder Irrigation Set is intended for the infusion of fluids to evacuate the bladder. It is also indicated for use in such procedures as cystoscopies and transurethral-resections as a means of continuous bladder irrigation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070873 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070873: Amsure Bladder Irrigation Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070873
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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