510(k) · Cleared
ClearedInspire HCR and HCR DUAL cardiotomy reservoirs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Italia S.R.L. · DTN Reservoir, Blood, Cardiopulmonary Bypass
Cleared on Dec 22, 2025 as substantially equivalent to K130433 (Sorin Group Italia S.R.L., 2013) and 1 other predicate after a 194-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- Dec 22, 2025
- Review
- 194 days
- Class
- Class II
- Product code
- DTN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K922933 (1992). 12 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 deviceK251783 Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L. · 2025
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) | 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 |
| 2012 | 2 | 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 DTN? 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 DTN device
- #1 K241206 Quantum Perfusion Hybrid Systemscore 9.2 · 6 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 |
|---|---|---|---|
| * | K130433 | Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire 8F Hollow…Summary page 6…nmodified models have the same fundamental scientific technology and intended use: 510(k) Number: K130433 Device Trade Name: INSPIRE 8 HOLLOW FIBER… | 2013 |
| * | K122844 | Inspire 8F Dual Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell…Summary page 6…ass II Classification Panel: Cardiovascular 510(k) Number: K122844 Device Trade Name: INSPIRE 8F DUAL HOLLOW… | 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 33 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K130433.
How does its category compare?
All DTN devicesDTN Reservoir, Blood, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DTN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTN
38in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTN
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTN
8in 2025
MAUDE reports naming product code DTN, 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 | 2 | — | 1 | 10 |
| 2008 | 1 | — | 1 | 8 |
| 2009 | 7 | 211 | 1 | 10 |
| 2010 | 1 | — | 0 | 18 |
| 2011 | 2 | — | 1 | 10 |
| 2012 | 0 | — | 0 | 17 |
| 2013 | 4 | 79 | 0 | 47 |
| 2014 | 3 | 38 | 0 | 52 |
| 2015 | 2 | — | 0 | 27 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 2 | — | 1 | 3 |
| 2018 | 0 | — | 2 | 4 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 2 | — | 0 | 10 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Inspire HCR and Inspire HCR DUAL cardiotomy reservoir are a device allowing suction blood recovery during extracorporeal circulation procedures, by providing blood collection and storage.
In addition, the device supports extracorporeal system priming and defoams and filters suctioned blood. The Inspire HCR must be used up to 6 hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251783 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251783: Inspire HCR and HCR DUAL cardiotomy reservoirs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251783
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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