510(k) · Cleared
Recalled · 2003Vci Suction/Irrigation Tubing Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vital Concepts, Inc. · JOL Catheter And Tip, Suction
Cleared on Feb 1, 1994 after a 145-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it. It has been recalled 10 times.
- Decided
- Feb 1, 1994
- Review
- 145 days
- Class
- Class II
- Product code
- JOL
- Recalls
- 10
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK934382 Vci Suction/Irrigation Tubing SetVital Concepts, Inc. · 1994
- Descendant · cites it directly · 1 of its ownK970946 Medline Y-Type Tur/Bladder Irrigation SetMedline Industries, Inc. · 1997
- Descendant · 2 generations on · 0 of its ownK070873 Amsure Bladder Irrigation SetAmsino Intl., Inc. · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934382 | Vci Suction/Irrigation Tubing Set | Vital Concepts, Inc. | 1994 | — |
| +1 | K970946 | Medline Y-Type Tur/Bladder Irrigation Set | Medline Industries, Inc. | 1997 | — |
| +2 | K070873 | Amsure Bladder Irrigation Set | Amsino Intl., Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JOL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K970946 | Medline Y-Type Tur/Bladder Irrigation Set | 1997 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 7, 2003 | Not classified | Z-0261-04 | Other | The probe may separate from the cannula. |
| Nov 7, 2003 | Not classified | Z-0260-04 | Other | The probe may separate from the cannula. |
| Nov 7, 2003 | Not classified | Z-0258-04 | Other | The probe may separate from the cannula. |
| Nov 7, 2003 | Not classified | Z-0259-04 | Other | The probe may separate from the cannula. |
| Jul 11, 2003 | Not classified | Z-0022-04 | Other | The suction valve may become stuck in the 'suction on' position under vacuum. |
| Jul 11, 2003 | Not classified | Z-0025-04 | Other | The suction valve may become stuck in the 'suction on' position under vacuum. |
| Jul 11, 2003 | Not classified | Z-0020-04 | Other | The suction valve may become stuck in the 'suction on' position under vacuum. |
| Jul 11, 2003 | Not classified | Z-0021-04 | Other | The suction valve may become stuck in the 'suction on' position under vacuum. |
| Jul 11, 2003 | Not classified | Z-0023-04 | Other | The suction valve may become stuck in the 'suction on' position under vacuum. |
| Jul 11, 2003 | Not classified | Z-0024-04 | Other | The suction valve may become stuck in the 'suction on' position under vacuum. |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K970946 (Medline Industries, Inc., 1997) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JOL devicesJOL Catheter And Tip, Suction: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JOL
FDA has decided no JOL device since 2007.
Median 510(k) review, days · JOL
Too few JOL 510(k)s in any year since 2007 to give a median.
Recalls per year · JOL
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · JOL
277in 2025
MAUDE reports naming product code JOL, 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 | 17 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 0 | — | 0 | 17 |
| 2010 | 0 | — | 0 | 25 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 0 | — | 1 | 25 |
| 2013 | 0 | — | 0 | 34 |
| 2014 | 0 | — | 0 | 42 |
| 2015 | 0 | — | 0 | 27 |
| 2016 | 0 | — | 0 | 61 |
| 2017 | 0 | — | 0 | 181 |
| 2018 | 0 | — | 0 | 161 |
| 2019 | 0 | — | 3 | 442 |
| 2020 | 0 | — | 0 | 187 |
| 2021 | 0 | — | 0 | 283 |
| 2022 | 0 | — | 0 | 221 |
| 2023 | 0 | — | 1 (1) | 197 |
| 2024 | 0 | — | 0 | 277 |
| 2025 | 0 | — | 0 | 277 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K934382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934382: Vci Suction/Irrigation Tubing Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934382
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026