510(k) · Cleared
ClearedD 100 L001 PH.I.S.I.O.: Newborn Hollow Fiber Membrane Oxygenator with Integrated Hardshell Cardiotomy/Venous Reservoir W
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 2, 2006 as substantially equivalent to K991737 (Dideco S.P.A., 2000) and 2 other predicates after a 49-day review. Its family tree reaches back 1 generation to 2000. 1 of the 17 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it.
- Decided
- Jun 2, 2006
- Review
- 49 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K991737 (2000). 3 ancestors in all. 13 later devices descend from it, 1 citing it directly. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK991737 Lilliput Phospholypidic Inert Surface in Oxygenation (PH.I.S.I.O.)…Dideco S.P.A. · 2000 · Recalled
- This deviceK061031 D 100 L001 PH.I.S.I.O.: Newborn Hollow Fiber Membrane Oxygenator…Sorin Group Italia S.R.L. · 2006
- Descendant · cites it directly · 12 of its ownK072091 D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2007
- Descendant · 2 generations on · 6 of its ownK103191 Quadrox-I Pediatric Microporous Membrane Oxygenator with Integrated…Maquet Cardiopulmonary, AG · 2011 · Recalled
- Descendant · 2 generations on · 6 of its ownK100278 Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline…Maquet Cardiopulmonary, AG · 2010 · Recalled
- Descendant · 3 generations on · 4 of its ownK132829 Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG · 2013 · Recalled
- Descendant · 4 generations on · 2 of its ownK150267 QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsMaquet Cardiopulmonary, AG · 2015 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K141432 Neonatal Venous Hardshell Cardiotomy Reservior…3 generations on · 2014
Most influential descendants
Showing 5 of 13 · See all- K072091D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated Hardshell…Sorin Group Italia S.R.L. · 2007 · cites it directly12descendants
- K103191Quadrox-I Pediatric Microporous Membrane Oxygenator with Integrated Arterial Filter with…Maquet Cardiopulmonary, AG · 2011 · 2 generations on6descendants
- K100278Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Models BE-Hmod…Maquet Cardiopulmonary, AG · 2010 · 2 generations on6descendants
- K132829Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG · 2013 · 3 generations on4descendants
- K150267QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsMaquet Cardiopulmonary, AG · 2015 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991737 | Lilliput Phospholypidic Inert Surface in Oxygenation (PH.I.S.I.O.)… | Dideco S.P.A. | 2000 | 1 |
| 0 (this device) | K061031 | D 100 L001 PH.I.S.I.O.: Newborn Hollow Fiber Membrane Oxygenator with… | Sorin Group Italia S.R.L. | 2006 | — |
| +1 | K072091 | D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated Hardshell… | Sorin Group Italia S.R.L. | 2007 | — |
| +2 | K103191 | Quadrox-I Pediatric Microporous Membrane Oxygenator with Integrated Arterial… | Maquet Cardiopulmonary, AG | 2011 | 4 |
| +2 | K100278 | Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating… | Maquet Cardiopulmonary, AG | 2010 | 4 |
| +3 | K132829 | Quadrox-I, Quadrox-ID, Quadrox-IR Oxygenators | Maquet Cardiopulmonary, AG | 2013 | 1 |
| +4 | K150267 | QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators | Maquet Cardiopulmonary, AG | 2015 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 1 |
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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.
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 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 |
|---|---|---|---|
| * | K991737 | Lilliput Phospholypidic Inert Surface in Oxygenation (PH.I.S.I.O.) Infant/Newborn Hollow…Summary page 1…ne coating (open and closed system) (hereafter referred to as D 901 Ph.l.S.I.O.) (K991737, K010478). PREDICATE DEVICE: D 901 Lilliput 1 Ph.I.S.I.O. Newborn… | 2000 |
| * | K010478 | Dideco D901 Lilliput Hollow Fiber Oxygenator with or Without Soft Venous Reservoir Bag…Summary page 1…g (open and closed system) (hereafter referred to as D 901 Ph.l.S.I.O.) (K991737, K010478). PREDICATE DEVICE: D 901 Lilliput 1 Ph.I.S.I.O. Newborn Ho… | 2001 |
| * | K001602 | Dideco Lilliput 1 Twin Reservoir with Phosphorilcholine Insert Surface in Oxygenation… | 2000 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072091 | D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated Hardshell… | 2007 | 12 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K072091 (Sorin Group Italia S.R.L., 2007) has gone furthest, with 12 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.
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 D 100 L001 Ph.l.S.I.O. Newborn-Hollow Fiber Membrane Oxygenator with Phosphorilcholine Coating is intended for use in infants who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a maximum blood flow rate of 0.7 liters/minute. It provides oxygenation and carbon dioxide removal from venous or suctioned blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in…
Read the full statement (131 words)
The D 100 L001 Ph.l.S.I.O. Newborn-Hollow Fiber Membrane Oxygenator with Phosphorilcholine Coating is intended for use in infants who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a maximum blood flow rate of 0.7 liters/minute. It provides oxygenation and carbon dioxide removal from venous or suctioned blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous reservoir is intended to collect blood aspirated from the operating field during surgical procedures and the blood from patient's veins (gravity or vacuum assisted) during normal operation, to always assure the proper oxygenation capability of the device. The D 100 L001 Ph.I.S.I.O. should not be used longer than 6 hours. Contact with blood for longer periods is not advised.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061031 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061031: D 100 L001 PH.I.S.I.O.: Newborn Hollow Fiber Membrane Oxygenator with Integrated Hardshell Cardiotomy/Venous Reservoir W.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061031
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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