510(k) · Cleared
ClearedMinimax (TM) Hardshell Venous Res W/Inte Card Filt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DTP Defoamer, Cardiopulmonary Bypass
Cleared on Aug 20, 1991 after a 120-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Aug 20, 1991
- Review
- 120 days
- Class
- Class II
- Product code
- DTP
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK911789 Minimax (TM) Hardshell Venous Res W/Inte Card FiltMedtronic Vascular · 1991
- Descendant · cites it directly · 4 of its ownK100645 Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or…Medtronic, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK141233 Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface…Medtronic, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK172984 Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie…Medtronic, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK160091 Temperature Probe, Affinity Temperature ProbeMedtronic, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK123448 Affinity Flexible Luer Lock Adapter with Balance Biosurface…Medtronic, Inc. · 2012
Most influential descendants
Showing 5 of 5 · See all- K100645Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance BiosurfaceMedtronic, Inc. · 2012 · cites it directly4descendants
- K141233Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance BiosufaceMedtronic, Inc. · 2014 · 2 generations on1descendant
- K172984Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with…Medtronic, Inc. · 2017 · 2 generations on0descendants
- K160091Temperature Probe, Affinity Temperature ProbeMedtronic, Inc. · 2016 · 2 generations on0descendants
- K123448Affinity Flexible Luer Lock Adapter with Balance Biosurface, Affinity Flexible Luer Lock…Medtronic, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911789 | Minimax (TM) Hardshell Venous Res W/Inte Card Filt | Medtronic Vascular | 1991 | — |
| +1 | K100645 | Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance… | Medtronic, Inc. | 2012 | — |
| +2 | K141233 | Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance… | Medtronic, Inc. | 2014 | — |
| +2 | K172984 | Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator… | Medtronic, Inc. | 2017 | — |
| +2 | K160091 | Temperature Probe, Affinity Temperature Probe | Medtronic, Inc. | 2016 | — |
| +2 | K123448 | Affinity Flexible Luer Lock Adapter with Balance Biosurface, Affinity Flexible… | Medtronic, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DTP? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 |
|---|---|---|---|
| K100645 | Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance Biosurface | 2012 | 4 |
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?
- Of its descendants, K100645 (Medtronic, Inc., 2012) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DTP devicesDTP Defoamer, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTP
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · DTP
Too few DTP 510(k)s in any year since 2007 to give a median.
Recalls per year · DTP
No recall names DTP since 2007.
Adverse event reports per year · DTP
1in 2016
MAUDE reports naming product code DTP, 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 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K911789 · printed Nov 5, 2026
Cite this page
510(k) Report. “K911789: Minimax (TM) Hardshell Venous Res W/Inte Card Filt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K911789
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026