510(k) · Cleared
ClearedMedline Y-Type Tur/Bladder Irrigation Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · LJH System, Irrigation, Urological
Cleared on Jun 10, 1997 as substantially equivalent to K934382 (Vital Concepts, Inc., 1994) after an 88-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Jun 10, 1997
- Review
- 88 days
- Class
- Class II
- Product code
- LJH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934382 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK934382 Vci Suction/Irrigation Tubing SetVital Concepts, Inc. · 1994 · Recalled
- This deviceK970946 Medline Y-Type Tur/Bladder Irrigation SetMedline Industries, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK070873 Amsure Bladder Irrigation SetAmsino Intl., Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K070873Amsure Bladder Irrigation SetAmsino Intl., Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934382 | Vci Suction/Irrigation Tubing Set | Vital Concepts, Inc. | 1994 | 10 |
| 0 (this device) | K970946 | Medline Y-Type Tur/Bladder Irrigation Set | Medline Industries, Inc. | 1997 | — |
| +1 | K070873 | Amsure Bladder Irrigation Set | Amsino Intl., Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 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? (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 |
|---|---|---|---|
| * | K934382 | Vci Suction/Irrigation Tubing SetSummary page 1…water only. Do not use with plasma products. Not intended for reuse. SUBSTANTIAL EQUIVALENCE Medline Industries, Inc. claims substantial equivalence to Vital Concepts, K934382 and Baxter Healthcare’s Y-Type TUR/Bladder Irrigation Set, which is pre-amendment exempt. Medline Y-Type TUR/Bladder Irrigation… | 1994 |
| * | — | Baxter Healthcare’s Y-Type TUR/Bladder Irrigation Set Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070873 | Amsure Bladder Irrigation Set | 2007 | 0 |
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 a recall.
- Of its descendants, K070873 (Amsino Intl., Inc., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LJH devicesLJH System, Irrigation, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Medline Y-Type TUR/Bladder Irrigation Set is Intended for the infusion of sterile solutions into the bladder to cleanse (evacuate) the contents of the bladder. It is also indicated for use in transurethral resection (prostrate or bladder surgery) as a means of continuous irrigation of the bladder
It is intended to be used with sterile solutions only. Not intended for reuse.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970946 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970946: Medline Y-Type Tur/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/K970946
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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