510(k) · Cleared
ClearedInspire 6 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Italia S.R.L. · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Apr 5, 2012 after a 119-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Apr 5, 2012
- Review
- 119 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK113626 Inspire 6 Hollow Fiber Oxygenator with Integrated Hardshell…Sorin Group Italia S.R.L. · 2012
- Descendant · cites it directly · 5 of its ownK180448 INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber…Sorin Group Italia S.R.L. · 2018
- Descendant · 2 generations on · 0 of its ownK261438 HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.L · 2026
- Descendant · 2 generations on · 0 of its ownK250821 Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and…Eurosets S.R.L · 2025
- Descendant · 2 generations on · 0 of its ownK212341 Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor…Qura S.R.L · 2022
- Descendant · 2 generations on · 0 of its ownK201916 Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber…Sorin Group Italia S.R.L. · 2020
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K180448INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2018 · cites it directly5descendants
- K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.L · 2026 · 2 generations on0descendants
- K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR)…Eurosets S.R.L · 2025 · 2 generations on0descendants
- K212341Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum…Qura S.R.L · 2022 · 2 generations on0descendants
- K201916Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M…Sorin Group Italia S.R.L. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K113626 | Inspire 6 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy… | Sorin Group Italia S.R.L. | 2012 | — |
| +1 | K180448 | INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with… | Sorin Group Italia S.R.L. | 2018 | — |
| +2 | K261438 | HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) | Eurosets S.R.L | 2026 | — |
| +2 | K250821 | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon… | Eurosets S.R.L | 2025 | — |
| +2 | K212341 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U… | Qura S.R.L | 2022 | — |
| +2 | K201916 | Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator… | Sorin Group Italia S.R.L. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | — | D 905 EOS: hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir Named without a submission number |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180448 | INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated… | 2018 | 5 |
| K130209 | Inspire 6 Hollow Fiber Oxygenator with Integrated Hardhell Reservoir, Inspire 6F Hollow… | 2013 | 0 |
| K121909 | Inspire 6 Dual Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy… | 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?
- Of its descendants, K180448 (Sorin Group Italia S.R.L., 2018) has gone furthest, with 5 descendants of its own.
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?
INSPIRE 6M: Hollow Fiber Oxygenator
INSPIRE 6M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 6M is intended to be used for 6 hours or less.
INSPIRE HVR: Hardshell Venous/Cardiotomy Reservoir
INSPIRE HVIR is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, defoams and filters venous blood and suction blood. INSPIRE HVIR can be used post-operatively for chest drainage. INSPIRE HVR is intended to be used for 6 hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113626: Inspire 6 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113626
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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