510(k) · Cleared
ClearedAffinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance Biosurface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Sep 14, 2012 as substantially equivalent to K000430 (Medtronic Vascular, 2000) and 5 other predicates after a 924-day review. Its family tree reaches back 2 generations to 1994. 4 later devices descend from it.
- Decided
- Sep 14, 2012
- Review
- 924 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 2 generations to K936003 (1994). 7 ancestors in all, the oldest K831528 (1983). 4 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK936003 Affinity CVRAvecor Cardiovascular, Inc. · 1994 · Recalled
- 1 generation backK021287 Trillium Affinity NT Cardiotomy Venous Reservoir, Models 540T, 541TTMedtronic Perfusion Systems · 2002 · Recalled
- This deviceK100645 Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or…Medtronic, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK141233 Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface…Medtronic, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK172984 Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie…Medtronic, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK160091 Temperature Probe, Affinity Temperature ProbeMedtronic, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK123448 Affinity Flexible Luer Lock Adapter with Balance Biosurface…Medtronic, Inc. · 2012
Most influential descendants
Showing 4 of 4 · See all- K141233Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance BiosufaceMedtronic, Inc. · 2014 · cites it directly1descendant
- K172984Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with…Medtronic, Inc. · 2017 · cites it directly0descendants
- K160091Temperature Probe, Affinity Temperature ProbeMedtronic, Inc. · 2016 · cites it directly0descendants
- K123448Affinity Flexible Luer Lock Adapter with Balance Biosurface, Affinity Flexible Luer Lock…Medtronic, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K936003 | Affinity CVR | Avecor Cardiovascular, Inc. | 1994 | 3 |
| −1 | K021287 | Trillium Affinity NT Cardiotomy Venous Reservoir, Models 540T, 541TT | Medtronic Perfusion Systems | 2002 | 1 |
| 0 (this device) | K100645 | Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance… | Medtronic, Inc. | 2012 | — |
| +1 | K141233 | Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance… | Medtronic, Inc. | 2014 | — |
| +1 | K172984 | Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator… | Medtronic, Inc. | 2017 | — |
| +1 | K160091 | Temperature Probe, Affinity Temperature Probe | Medtronic, Inc. | 2016 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 DTZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DTZ device
- #1 K240934 Quantum Perfusion Blood Oxygenator ECC…score 14.3 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000430 | Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Carmeda Bioactive…Summary page 1…, DTP FLL Classification: Class 11 Class II Class 11 Predicate Devices Medtronic AFFINITY NT® Oxygenator with Carmeda (K000430) Medltronic AFFINITY NT Oxygenator with Trillium (14973760) Medtronic Minimaxe Plus Oxygenator with Carmeda (14933586) Medtronic… | 2000 |
| * | K973760 | Affinity Hollow Fiber Oxygenator with Trillium Biopassive SurfaceSummary page 1…Class II Class 11 Predicate Devices Medtronic AFFINITY NT® Oxygenator with Carmeda (K000430) Medltronic AFFINITY NT Oxygenator with Trillium (14973760) Medtronic Minimaxe Plus Oxygenator with Carmeda (14933586) Medtronic AFFINITY NT Cardiotomy/Venous Reservoir with Trillium (K02… | 1998 |
| * | K933586 | Minimax Plus Hollow Fiber Oxygenator (with or Without Medtronic/Carmeda Bioactive SurfaceSummary page 1…es Medtronic AFFINITY NT® Oxygenator with Carmeda (K000430) Medltronic AFFINITY NT Oxygenator with Trillium (14973760) Medtronic Minimaxe Plus Oxygenator with Carmeda (14933586) Medtronic AFFINITY NT Cardiotomy/Venous Reservoir with Trillium (K02 1287) Medtronic Minimax Cardiotomy/Venous Reservoir (149117… | 1994 |
| * | K021287 | Trillium Affinity NT Cardiotomy Venous Reservoir, Models 540T, 541TTSummary page 1…FINITY NT Oxygenator with Trillium (14973760) Medtronic Minimaxe Plus Oxygenator with Carmeda (14933586) Medtronic AFFINITY NT Cardiotomy/Venous Reservoir with Trillium (K02 1287) Medtronic Minimax Cardiotomy/Venous Reservoir (14911789) Medtronic Thermistor Probe (K83 1528) Terumo Capiox RX05 Oxygenator wit… | 2002 |
| * | K911789 | Minimax (TM) Hardshell Venous Res W/Inte Card FiltSummary page 1…imaxe Plus Oxygenator with Carmeda (14933586) Medtronic AFFINITY NT Cardiotomy/Venous Reservoir with Trillium (K02 1287) Medtronic Minimax Cardiotomy/Venous Reservoir (14911789) Medtronic Thermistor Probe (K83 1528) Terumo Capiox RX05 Oxygenator with and without Reservoir (K4022115) Device Description Th… | 1991 |
| * | K831528 | Model TP Thermistor ProbeSummary page 1…14933586) Medtronic AFFINITY NT Cardiotomy/Venous Reservoir with Trillium (K02 1287) Medtronic Minimax Cardiotomy/Venous Reservoir (14911789) Medtronic Thermistor Probe (K83 1528) Terumo Capiox RX05 Oxygenator with and without Reservoir (K4022115) Device Description The Affinity Pixie Oxygenation System wi… | 1983 |
| Kept off the family tree | K042115 | Terumo Capiox RX05 Oxygenator with and without Reservoir Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141233 | Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance Biosuface | 2014 | 1 |
| K172984 | Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with… | 2017 | 0 |
| K160091 | Temperature Probe, Affinity Temperature Probe | 2016 | 0 |
| K123448 | Affinity Flexible Luer Lock Adapter with Balance Biosurface, Affinity Flexible Luer Lock… | 2012 | 0 |
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 10.4 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K141233 (Medtronic, Inc., 2014) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K000430.
How does its category compare?
All DTZ devicesDTZ Oxygenator, 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 · DTZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTZ
124in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTZ
1in 2025
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DTZ
976in 2025
MAUDE reports naming product code DTZ, 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 | 4 | 55 | 7 | 134 |
| 2008 | 3 | 88 | 5 | 105 |
| 2009 | 9 | 210 | 0 | 52 |
| 2010 | 2 | — | 1 | 119 |
| 2011 | 4 | 160 | 13 | 190 |
| 2012 | 9 | 90 | 14 | 215 |
| 2013 | 9 | 28 | 0 | 346 |
| 2014 | 5 | 28 | 2 | 764 |
| 2015 | 9 | 134 | 0 | 658 |
| 2016 | 3 | 62 | 1 | 443 |
| 2017 | 2 | — | 0 | 388 |
| 2018 | 3 | 72 | 2 (2) | 320 |
| 2019 | 5 | 90 | 1 | 489 |
| 2020 | 5 | 93 | 3 | 442 |
| 2021 | 5 | 336 | 1 (1) | 595 |
| 2022 | 2 | — | 6 | 559 |
| 2023 | 5 | 145 | 0 | 738 |
| 2024 | 3 | 124 | 0 | 535 |
| 2025 | 2 | — | 1 | 976 |
| 2026 | 3 | 137 | 0 | — |
What is it indicated for?
Oxygenator: The Affinity Pixie Hollow Fiber Oxygenator with Carmeda BioActive Surface or Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. Cardiotomy Venous Reservoir: The Affinity Pixie Cardiotomy/Venous Reservoir with Carmeda BioActive Surface or Balance Biosurface…
Read the full statement (160 words)
Oxygenator: The Affinity Pixie Hollow Fiber Oxygenator with Carmeda BioActive Surface or Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
Cardiotomy Venous Reservoir: The Affinity Pixie Cardiotomy/Venous Reservoir with Carmeda BioActive Surface or Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.
Temperature Probe: The Affinity Temperature Probe is intended for use for continuous blood temperature monitoring as measured at a temperature monitoring adapter located within a Medtronic extracorporeal circulation device as specified in the device's Instructions for Use. The Temperature Probe is designed for use with a Y5jTM Tele-thermometer to monitor and display temperature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100645 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100645: Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or 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/K100645
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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