510(k) · Cleared
Recalled · Class II · 2015Connector Components with 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 Oct 12, 2012 as substantially equivalent to K113845 (Medtronic, Inc., 2012) after a 29-day review. Its family tree reaches back 3 generations to 1980. 5 later devices descend from it. It has been recalled once.
- Decided
- Oct 12, 2012
- Review
- 29 days
- Class
- Class II
- Product code
- DTL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K800178 (1980). 6 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK800178 Extracorp.'S Intersept Cus. Tubing PK.Extracorporeal Medical Specialities, Inc. · 1980 · Recalled
- 2 generations backK012538 Tubing and Connectors with Trillium Biopassive SurfaceMedtronic Vascular · 2001 · Recalled
- 1 generation backK113845 Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceMedtronic, Inc. · 2012 · Recalled
- This deviceK122811 Connector Components with Balance BiosurfaceMedtronic, Inc. · 2012
- 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
- Descendant · 4 generations on · 0 of its ownK213540 Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia SetQura S.R.L · 2022
Most influential descendants
Showing 5 of 5 · See all- 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
- K213540Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia SetQura S.R.L · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K800178 | Extracorp.'S Intersept Cus. Tubing PK. | Extracorporeal Medical Specialities, Inc. | 1980 | 10 |
| −2 | K012538 | Tubing and Connectors with Trillium Biopassive Surface | Medtronic Vascular | 2001 | 5 |
| −1 | K113845 | Tubing, Conmnectors, and Accessories Wit Balance Biosurface | Medtronic, Inc. | 2012 | 1 |
| 0 (this device) | K122811 | Connector Components with Balance Biosurface | Medtronic, Inc. | 2012 | — |
| +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 | — |
| +4 | K213540 | Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set | Qura S.R.L | 2022 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K113845 | Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceSummary page 1…manifold or fitting Regulation Number: 21 CFR 870.4290 Product Codes: DTL and DWF Product Classification: Class 11 Predicate Device K1 13845 Tubing, Connectors and Accessories, with Balance® Biosurface… | 2012 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151523 | Uncoated Tubing and Connector Components | 2015 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 18, 2015 | Class II | Z-2736-2015 | Nonconforming Material/Component | Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone devices and in specific lots of Medtronic… |
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 10.4 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K151523 (Medtronic, Inc., 2015) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K113845.
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?
Medtronic Connector Components with BalanceTM Biosurface are indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122811: Connector Components with 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/K122811
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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