510(k) · Cleared
Recalled · Class II · 2023Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy Reservoir, Neonatal Venous Hardshe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet Cardiopulmonary, AG · DTN Reservoir, Blood, Cardiopulmonary Bypass
Cleared on Mar 11, 2011 as substantially equivalent to K022115 (Terumo Corp., 2002) and 2 other predicates after a 161-day review. Its family tree reaches back 8 generations to 1992. 1 of the 31 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Mar 11, 2011
- Review
- 161 days
- Class
- Class II
- Product code
- DTN
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 8 generations to K922933 (1992). 29 ancestors in all, the oldest K842908 (1985). 1 later device descends from it, 1 citing it directly. 1 of the 31 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 7 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 6 generations backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- 5 generations backK022450 Integrated Unit: Synthesis: Adult Membrane Oxygenator with…Dideco S.P.A. · 2002
- 4 generations backK031223 Synthesis Mimesys Adult Membrane OxygenatorDideco S.P.A. · 2003
- 3 generations backK073380 Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2008 · Recalled
- 2 generations backK082117 Quadrox-I Adult with and Without Integrated Arterial Filter with…Maquet Cardiopulmonary, AG · 2009 · Recalled
- 1 generation backK090534 Venous Hardshell Cardiotomy ReserviorsMaquet Cardiopulmonary, AG · 2009
- This deviceK102919 Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous…Maquet Cardiopulmonary, AG · 2011
- Descendant · cites it directly · 0 of its ownK141432 Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous…Maquet Cardiopulmonary, AG · 2014 · Recalled (Class I)
Class I recalls in this family
- K141432 Neonatal Venous Hardshell Cardiotomy Reservior…cites it directly · 2014
Most influential descendants
Showing 1 of 1 · See all- K141432Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy…Maquet Cardiopulmonary, AG · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −7 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −6 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| −5 | K022450 | Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial… | Dideco S.P.A. | 2002 | — |
| −4 | K031223 | Synthesis Mimesys Adult Membrane Oxygenator | Dideco S.P.A. | 2003 | — |
| −3 | K073380 | Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial… | Sorin Group Italia S.R.L. | 2008 | 1 |
| −2 | K082117 | Quadrox-I Adult with and Without Integrated Arterial Filter with Softline… | Maquet Cardiopulmonary, AG | 2009 | 5 |
| −1 | K090534 | Venous Hardshell Cardiotomy Reserviors | Maquet Cardiopulmonary, AG | 2009 | — |
| 0 (this device) | K102919 | Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell… | Maquet Cardiopulmonary, AG | 2011 | — |
| +1 | K141432 | Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell… | Maquet Cardiopulmonary, AG | 2014 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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 K251783 Inspire HCR and HCR DUAL cardiotomy reservoirsscore 12.4 · 7 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 |
|---|---|---|---|
| * | K022115 | Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell ReservoirSummary page 1…ss defoamer, Cardiopulmonary bypass cardiotomy suction line Predicate Devices: Capiox Resevoir RX 05R Baby, Terumo Cardiovascular Systems Corp (K022115), Resevoir D1i01 Dideco Kids Infant with Ph.l.S.LO0. Coating, Sorin (K072091), Venous Hardshell Cardiotomy Reservoir with SOFTLIN… | 2002 |
| * | K072091 | D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated Hardshell…Summary page 1…ion line Predicate Devices: Capiox Resevoir RX 05R Baby, Terumo Cardiovascular Systems Corp (K022115), Resevoir D1i01 Dideco Kids Infant with Ph.l.S.LO0. Coating, Sorin (K072091), Venous Hardshell Cardiotomy Reservoir with SOFTLINE Coating (K090534), MAQUET Cardiopulmonary AG.… | 2007 |
| * | K090534 | Venous Hardshell Cardiotomy ReserviorsSummary page 1…ascular Systems Corp (K022115), Resevoir D1i01 Dideco Kids Infant with Ph.l.S.LO0. Coating, Sorin (K072091), Venous Hardshell Cardiotomy Reservoir with SOFTLINE Coating (K090534), MAQUET Cardiopulmonary AG. MAQUET… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141432 | Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy… Class I | 2014 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 18, 2023 | Class II | Z-1661-2023 | Under Investigation by firm | Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia. |
| May 18, 2023 | Class II | Z-1642-2023 | Pending | 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K141432Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy Reservior, Neonatal…Maquet Cardiopulmonary, AG · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 29 ancestors have a recall of any class.
- Of its descendants, K141432 (Maquet Cardiopulmonary, AG, 2014) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K022115.
How does its category compare?
All DTN devicesDTN Reservoir, Blood, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 venous hardshell cardiotomy reservoir is used to collect, store and filter blood in extracorporeal circulation, in cardiopulmonary bypass operations on pediatric patients for up to 6 hours;
The reservoir can also be employed postoperatively as drainage and autotransfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102919: Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy Reservoir, Neonatal Venous Hardshe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102919
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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