510(k) · Cleared
Recalled · Class II · 2012Tubing, Conmnectors, and Accessories Wit Balance Biosurface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Cleared on Jan 25, 2012 as substantially equivalent to K800178 (Extracorporeal Medical Specialities, Inc., 1980) and 4 other predicates after a 28-day review. Its family tree reaches back 2 generations to 1980. 7 later devices descend from it. It has been recalled once.
- Decided
- Jan 25, 2012
- Review
- 28 days
- Class
- Class II
- Product code
- DTL
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 2 generations to K800178 (1980). 5 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK800178 Extracorp.'S Intersept Cus. Tubing PK.Extracorporeal Medical Specialities, Inc. · 1980 · Recalled
- 1 generation backK012538 Tubing and Connectors with Trillium Biopassive SurfaceMedtronic Vascular · 2001 · Recalled
- This deviceK113845 Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceMedtronic, Inc. · 2012
- Descendant · cites it directly · 5 of its ownK122811 Connector Components with Balance BiosurfaceMedtronic, Inc. · 2012 · Recalled
- Descendant · cites it directly · 4 of its ownK151523 Uncoated Tubing and Connector ComponentsMedtronic, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK171308 Tubing PackMedtronic, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 2 of its ownK171979 Tubing PackMedtronic, Inc. · 2017 · Recalled
- Descendant · 4 generations on · 0 of its ownK260043 Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary…Smart Reactors · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K122811Connector Components with Balance BiosurfaceMedtronic, Inc. · 2012 · cites it directly5descendants
- K151523Uncoated Tubing and Connector ComponentsMedtronic, Inc. · 2015 · cites it directly4descendants
- K171308Tubing PackMedtronic, Inc. · 2017 · 2 generations on3descendants
- K171979Tubing PackMedtronic, Inc. · 2017 · 3 generations on2descendants
- K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart Reactors · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K800178 | Extracorp.'S Intersept Cus. Tubing PK. | Extracorporeal Medical Specialities, Inc. | 1980 | 10 |
| −1 | K012538 | Tubing and Connectors with Trillium Biopassive Surface | Medtronic Vascular | 2001 | 5 |
| 0 (this device) | K113845 | Tubing, Conmnectors, and Accessories Wit Balance Biosurface | Medtronic, Inc. | 2012 | — |
| +1 | K122811 | Connector Components with Balance Biosurface | Medtronic, Inc. | 2012 | 1 |
| +1 | K151523 | Uncoated Tubing and Connector Components | Medtronic, Inc. | 2015 | — |
| +2 | K171308 | Tubing Pack | Medtronic, Inc. | 2017 | 1 |
| +3 | K171979 | Tubing Pack | Medtronic, Inc. | 2017 | 25 |
| +4 | K260043 | Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set… | Smart Reactors | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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 DTL? 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? (5)
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 |
|---|---|---|---|
| * | K800178 | Extracorp.'S Intersept Cus. Tubing PK.Summary page 1…on Number: 21 CFR 870.4290 Product Code: DWF and DTL Product Code: Class 11 Predicate Devices Intersept Custom Tubing Pack (K800 178) Bio-Medicus Tubing Connectors (K883956) Signature Custom Tubing Pack (K924529) Trillium Coated Tubing an… | 1980 |
| * | K883956 | Bio-Medicus Tubing ConnectorsSummary page 1…DWF and DTL Product Code: Class 11 Predicate Devices Intersept Custom Tubing Pack (K800 178) Bio-Medicus Tubing Connectors (K883956) Signature Custom Tubing Pack (K924529) Trillium Coated Tubing and Connectors (KO 12538) Affinity PixieTM… | 1988 |
| * | K924529 | Signature (TM) Custom Tubing PackSummary page 1…lass 11 Predicate Devices Intersept Custom Tubing Pack (K800 178) Bio-Medicus Tubing Connectors (K883956) Signature Custom Tubing Pack (K924529) Trillium Coated Tubing and Connectors (KO 12538) Affinity PixieTM Arterial Filter with BalanceTm Biosurface (K10… | 1993 |
| * | K012538 | Tubing and Connectors with Trillium Biopassive Surface | 2001 |
| * | K100646 | Affinity Pixie Arterial Filter with Balance BiosurfaceSummary page 1…Signature Custom Tubing Pack (K924529) Trillium Coated Tubing and Connectors (KO 12538) Affinity PixieTM Arterial Filter with BalanceTm Biosurface (K100646) Device Description Tubing, Connectors, and Accessories with BalanceTh Biosurface are used in cardiopulm… | 2010 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 19, 2012 | Class II | Z-0618-2013 | Package design/selection | Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptible to damage that can compromise product sterility. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 21.5 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K122811 (Medtronic, Inc., 2012) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K800178.
How does its category compare?
All DTL devicesDTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DTL
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · DTL
36in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTL
1in 2025
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DTL
110in 2025
MAUDE reports naming product code DTL, 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 | 1 | — | 0 | 37 |
| 2008 | 5 | 85 | 1 | 16 |
| 2009 | 2 | — | 0 | 62 |
| 2010 | 4 | 115 | 3 | 148 |
| 2011 | 0 | — | 1 | 160 |
| 2012 | 8 | 36 | 2 | 53 |
| 2013 | 1 | — | 1 (1) | 67 |
| 2014 | 2 | — | 1 | 80 |
| 2015 | 1 | — | 0 | 89 |
| 2016 | 0 | — | 0 | 67 |
| 2017 | 0 | — | 2 | 106 |
| 2018 | 0 | — | 0 | 84 |
| 2019 | 0 | — | 0 | 76 |
| 2020 | 0 | — | 0 | 53 |
| 2021 | 0 | — | 0 | 55 |
| 2022 | 0 | — | 2 | 48 |
| 2023 | 0 | — | 0 | 46 |
| 2024 | 0 | — | 0 | 452 |
| 2025 | 0 | — | 1 | 110 |
| 2026 | 0 | — | 3 (3) | — |
What is it indicated for?
This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113845 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113845: Tubing, Conmnectors, and Accessories Wit Balance Biosurface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113845
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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