510(k) · Cleared
ClearedAffinity Flexible Luer Lock Adapter with Balance Biosurface, Affinity Flexible Luer Lock Adapter with Carmeda Bioactive
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 Dec 13, 2012 as substantially equivalent to K100645 (Medtronic, Inc., 2012) after a 35-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Dec 13, 2012
- Review
- 35 days
- Class
- Class II
- Product code
- DTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K936003 (1994). 8 ancestors in all, the oldest K831528 (1983). No later device cites it as a predicate yet.
- Root · 3 generations backK936003 Affinity CVRAvecor Cardiovascular, Inc. · 1994 · Recalled
- 2 generations backK021287 Trillium Affinity NT Cardiotomy Venous Reservoir, Models 540T, 541TTMedtronic Perfusion Systems · 2002 · Recalled
- 1 generation backK100645 Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or…Medtronic, Inc. · 2012
- This deviceK123448 Affinity Flexible Luer Lock Adapter with Balance Biosurface…Medtronic, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K936003 | Affinity CVR | Avecor Cardiovascular, Inc. | 1994 | 3 |
| −2 | K021287 | Trillium Affinity NT Cardiotomy Venous Reservoir, Models 540T, 541TT | Medtronic Perfusion Systems | 2002 | 1 |
| −1 | K100645 | Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance… | Medtronic, Inc. | 2012 | — |
| 0 (this device) | K123448 | Affinity Flexible Luer Lock Adapter with Balance Biosurface, Affinity Flexible… | Medtronic, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K100645 | Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance BiosurfaceSummary page 1…cular Predicate Device The predicate device is the Affinity® Flexible Luer Lock Adapters, accessory packaged with the Affinity Pixie® Cardiotomy/Venous Reservoir (CVR) (K1 00645). Device Description The flexible luer lock adapters are single use only devices that consist of a flexible tubing segment with… | 2012 |
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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- 4 of the 8 ancestors have a recall of any class.
- 3 other devices also cite its predicate K100645.
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?
Flexible Luer Lock Adapters are indicated for use in connecting tubing and/or devices during cardiopulmonary bypass procedures up to 6 hours in duration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123448: Affinity Flexible Luer Lock Adapter with Balance Biosurface, Affinity Flexible Luer Lock Adapter with Carmeda Bioactive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123448
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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