510(k) · Cleared
ClearedINSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and 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 Jun 12, 2020 as substantially equivalent to K130433 (Sorin Group Italia S.R.L., 2013) and 2 other predicates after an 88-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- Jun 12, 2020
- Review
- 88 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K922933 (1992). 21 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 6 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 5 generations backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- 4 generations backK033323 D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2…Dideco S.P.A. · 2004 · Recalled
- 3 generations backK121229 Inspire 8 Dual Hollow Fiber Oxygenator with with Integrated…Sorin Group Italia S.R.L. · 2012
- 2 generations backK122254 Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell…Sorin Group Italia S.R.L. · 2012
- 1 generation backK130433 Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell…Sorin Group Italia S.R.L. · 2013 · Recalled
- This deviceK200683 INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter…Sorin Group Italia S.R.L. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −6 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −5 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| −4 | 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 |
| −3 | K121229 | Inspire 8 Dual Hollow Fiber Oxygenator with with Integrated Hardshell… | Sorin Group Italia S.R.L. | 2012 | — |
| −2 | K122254 | Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy… | 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 |
| 0 (this device) | K200683 | INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE… | Sorin Group Italia S.R.L. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2018 | 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? (3)
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 |
|---|---|---|---|
| * | K130433 | Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire 8F Hollow…Summary page 10…ed predicate device. Both models have the same fundamental scientific technology and intended use: 510(k) Number: K130433 Proprietary Name: INSPIRE 8F Hollow Fiber Oxygenator with h… | 2013 |
| * | K180448 | INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated…Summary page 10…llowing cleared predicate device. Both models have the same fundamental scientific technology and intended use: 510(k) Number: K180448 Proprietary Name: INSPIRE 8F M Hollow Fiber Oxygenator Common/Usual Name: INSP… | 2018 |
| * | K122844 | Inspire 8F Dual Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell…Summary page 10…ed predicate device. Both models have the same fundamental scientific technology and intended use: 510(k) Number: K122844 Proprietary Name: INSPIRE 8F Dual Hollow Fiber Oxygenator 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 28 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 5 of the 21 ancestors have a recall of any class.
- 1 other device also cites its predicate K130433.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The Inspire 7F M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The integrated arterial filter provides additional protection against air and solid emboli. The Inspire 7F M is intended to be used for 6 hours or less. The Inspire 7F is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides…
Read the full statement (157 words)
The Inspire 7F M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The integrated arterial filter provides additional protection against air and solid emboli. The Inspire 7F M is intended to be used for 6 hours or less.
The Inspire 7F is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The integrated arterial filter provides additional protection against air and solid emboli. The Inspire 7F is intended to be used for 6 hours or less.
The Inspire 7F Dual is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The integrated arterial filter provides additional protection against air and solid emboli. The Inspire 7F Dual is intended to be used for 6 hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200683: INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and 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/K200683
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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