510(k) · Cleared
ClearedInspire 8F Oxygenator with Integrated Arterial Filter & Hardshell 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 Aug 22, 2012 as substantially equivalent to K033323 (Dideco S.P.A., 2004) and 1 other predicate after a 90-day review. Its family tree reaches back 4 generations to 1992. 10 later devices descend from it.
- Decided
- Aug 22, 2012
- Review
- 90 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K922933 (1992). 7 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 3 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 2 generations backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- 1 generation backK033323 D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2…Dideco S.P.A. · 2004 · Recalled
- This deviceK121536 Inspire 8F Oxygenator with Integrated Arterial Filter & 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 · cites it directly · 3 of its ownK122844 Inspire 8F Dual Hollow Fiber Oxygenator with Integrated Arterial…Sorin Group Italia S.R.L. · 2012
- Descendant · cites it directly · 2 of its ownK130433 Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell…Sorin Group Italia S.R.L. · 2013 · Recalled
- 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 ownK251783 Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · 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
- K122844Inspire 8F Dual Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell…Sorin Group Italia S.R.L. · 2012 · cites it directly3descendants
- K130433Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire 8F Hollow…Sorin Group Italia S.R.L. · 2013 · cites it directly2descendants
- K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.L · 2026 · 2 generations on0descendants
- K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −3 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −2 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| −1 | K033323 | D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 PH.I.S.I.O. Adult… | Dideco S.P.A. | 2004 | 1 |
| 0 (this device) | K121536 | Inspire 8F Oxygenator with Integrated Arterial Filter & Hardshell Reservoir | 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 | — |
| +1 | K122844 | Inspire 8F Dual Hollow Fiber Oxygenator with Integrated Arterial Filter and… | Sorin Group Italia S.R.L. | 2012 | — |
| +1 | K130433 | Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire… | Sorin Group Italia S.R.L. | 2013 | 1 |
| +2 | K261438 | HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) | Eurosets S.R.L | 2026 | — |
| +2 | K251783 | Inspire HCR and HCR DUAL cardiotomy reservoirs | Sorin Group Italia S.R.L. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
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 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K033323 | D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 PH.I.S.I.O. Adult Hollow…Summary page 1…Filter PREDICATE DEVICE: 0903 AVANT 2 Ph.l.S.l.O. Adult Hollow Fiber Oxygenator with Ph.l .S.1.0. coating (K033323) Micro 40 Ph.l.S.l.O. Adult Arterial Filter (K0401… | 2004 |
| * | K040184 | Dideco Micro 40 PH.I.S.I.O. Adult Arterial FilterSummary page 1…Oxygenator with Ph.l .S.1.0. coating (K033323) Micro 40 Ph.l.S.l.O. Adult Arterial Filter (K0401 84) DEVICE DESCRIPTION: The INSPIRE 8F consists of an oxygenator, integrated with an arterial filter and a heat exchanger (INSPIRE… | 2004 |
What descends from it? (10)
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 |
| K122844 | Inspire 8F Dual Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell… | 2012 | 3 |
| K130433 | Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire 8F Hollow… | 2013 | 2 |
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 20 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K180448 (Sorin Group Italia S.R.L., 2018) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K033323.
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 8F M: Hollow Fiber Oxygenator The INSPIRE 8F M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control, INSPIRE SF M integrated arterial filter provides additional protection against air and solid emboli. INSPIRE 8F M is intended to be used for 6 hours or less. INSPIRE HVR: Hardshell Venous/Cardiotomy Reservoir INSPIRE HVR is intended for use…
Read the full statement (112 words)
INSPIRE 8F M: Hollow Fiber Oxygenator
The INSPIRE 8F M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control, INSPIRE SF M integrated arterial filter provides additional protection against air and solid emboli. INSPIRE 8F M is intended to be used for 6 hours or less.
INSPIRE HVR: Hardshell Venous/Cardiotomy Reservoir
INSPIRE HVR 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 HVR 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/K121536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121536: Inspire 8F Oxygenator with Integrated Arterial Filter & Hardshell Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121536
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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