510(k) · Cleared
ClearedSMARxT Tubing and Connectors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
LivaNova USA, Inc. · DWE Tubing, Pump, Cardiopulmonary Bypass
Cleared on Aug 8, 2024 as substantially equivalent to K981613 (Cobe Cardiovascular, Inc., 1998) after a 265-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Aug 8, 2024
- Review
- 265 days
- Class
- Class II
- Product code
- DWE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981613 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK981613 Cobe Smarxt Tubing and ConnectorsCobe Cardiovascular, Inc. · 1998 · Recalled
- This deviceK233702 SMARxT Tubing and ConnectorsLivaNova USA, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981613 | Cobe Smarxt Tubing and Connectors | Cobe Cardiovascular, Inc. | 1998 | 18 |
| 0 (this device) | K233702 | SMARxT Tubing and Connectors | LivaNova USA, Inc. | 2024 | — |
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 DWE? 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? (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 |
|---|---|---|---|
| * | K981613 | Cobe Smarxt Tubing and ConnectorsSummary page 4…nary bypass pump tubing Tubing, Pump, Cardiopulmonary Bypass 870.4390 DWE Predicate Trade Name (Primary Predicate is listed first) 21 CFR 807.92(a)(3) Product Code K981613 SMARXT Tubing and Connectors DWE Device Description Summary 21 CFR 807.92(a)(4) The SMARXT Tubing and Connectors, subjects o… | 1998 |
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 a recall.
How does its category compare?
All DWE devicesDWE Tubing, Pump, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · DWE
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DWE
Too few DWE 510(k)s in any year since 2007 to give a median.
Recalls per year · DWE
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWE
80in 2025
MAUDE reports naming product code DWE, 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 | — | 2 | 10 |
| 2008 | 1 | — | 0 | 12 |
| 2009 | 1 | — | 1 | 17 |
| 2010 | 0 | — | 2 | 20 |
| 2011 | 0 | — | 2 | 9 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 21 |
| 2014 | 1 | — | 1 | 129 |
| 2015 | 1 | — | 0 | 133 |
| 2016 | 0 | — | 0 | 151 |
| 2017 | 0 | — | 2 | 131 |
| 2018 | 0 | — | 0 | 134 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 45 |
| 2021 | 0 | — | 0 | 41 |
| 2022 | 0 | — | 0 | 123 |
| 2023 | 0 | — | 0 | 286 |
| 2024 | 1 | — | 0 | 221 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SMARxT Tubing and Connectors, a part of the Heart/Lung Perfusion Pack, are intended to be used in surgical procedures requiring extracorporeal support for periods of up to six hours.
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/K233702 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233702: SMARxT Tubing and Connectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233702
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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