510(k) Report

510(k) · Cleared

Recalled · 2008

Lilliput Phospholypidic Inert Surface in Oxygenation (PH.I.S.I.O.) Infant/Newborn Hollow Fiber Oxygenator

K991737510(k) TraditionalCleared Feb 17, 2000272-day reviewClass II21 CFR 870.4350Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dideco S.P.A. · DTZ Oxygenator, Cardiopulmonary Bypass

Cleared on Feb 17, 2000 after a 272-day review. The FDA summary names no predicate by number. 1 of the 15 devices in its family, counting itself, has a Class I recall. 14 later devices descend from it. It has been recalled once.

Decided
Feb 17, 2000
Review
272 days
Class
Class II
Product code
DTZ
Recalls
1
Predicates
0

14 later devices descend from it, 1 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2006: 1 descendant cleared2007: 1 descendant cleared2011: 3 descendants cleared2023: 2 descendants cleared2010: 1 descendant cleared2013: 2 descendants cleared2014: 1 descendant cleared, 1 with a Class I recall12015: 1 descendant cleared2021: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK991737 Lilliput Phospholypidic Inert Surface in Oxygenation (PH.I.S.I.O.)…Dideco S.P.A. · 2000
  2. Descendant · cites it directly · 13 of its ownK061031 D 100 L001 PH.I.S.I.O.: Newborn Hollow Fiber Membrane Oxygenator…Sorin Group Italia S.R.L. · 2006
  3. Descendant · 2 generations on · 12 of its ownK072091 D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2007
  4. Descendant · 3 generations on · 6 of its ownK103191 Quadrox-I Pediatric Microporous Membrane Oxygenator with Integrated…Maquet Cardiopulmonary, AG · 2011 · Recalled
  5. Descendant · 3 generations on · 6 of its ownK100278 Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline…Maquet Cardiopulmonary, AG · 2010 · Recalled
  6. Descendant · 4 generations on · 4 of its ownK132829 Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG · 2013 · Recalled

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12010: 12011: 32013: 22014: 12015: 12021: 12023: 22026: 1
2006high 3 (2011) · low 0 (2008)2026

Class I recalls in this family

  • K141432 Neonatal Venous Hardshell Cardiotomy Reservior…4 generations on · 2014

Most influential descendants

Showing 5 of 14 · See all
  • K061031D 100 L001 PH.I.S.I.O.: Newborn Hollow Fiber Membrane Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2006 · cites it directly13descendants
  • K072091D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated Hardshell…Sorin Group Italia S.R.L. · 2007 · 2 generations on12descendants
  • K103191Quadrox-I Pediatric Microporous Membrane Oxygenator with Integrated Arterial Filter with…Maquet Cardiopulmonary, AG · 2011 · 3 generations on6descendants
  • K100278Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Models BE-Hmod…Maquet Cardiopulmonary, AG · 2010 · 3 generations on6descendants
  • K132829Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG · 2013 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K991737Lilliput Phospholypidic Inert Surface in Oxygenation (PH.I.S.I.O.)…Dideco S.P.A.2000—
+1K061031D 100 L001 PH.I.S.I.O.: Newborn Hollow Fiber Membrane Oxygenator with…Sorin Group Italia S.R.L.2006—
+2K072091D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated Hardshell…Sorin Group Italia S.R.L.2007—
+3K103191Quadrox-I Pediatric Microporous Membrane Oxygenator with Integrated Arterial…Maquet Cardiopulmonary, AG20114
+3K100278Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating…Maquet Cardiopulmonary, AG20104
+4K132829Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG20131

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
201010
201130
201320
201411
201510
202110
202320
202610
FIG. 1 — Lineage of K991737, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K240934 Quantum Perfusion Blood Oxygenator ECC…score 14.3 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (14)

See all 14

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061031D 100 L001 PH.I.S.I.O.: Newborn Hollow Fiber Membrane Oxygenator with Integrated…Sorin Group Italia S.R.L.200613

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 8, 2008Not classifiedZ-2469-2008Labeling False and MisleadingUnder certain conditions, venous reservoir on oxygenator may allow air into the system.

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 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

  • Of its descendants, K061031 (Sorin Group Italia S.R.L., 2006) has gone furthest, with 13 descendants of its own.

How does its category compare?

All DTZ devices

DTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTZ

2in 2025

2007: 42008: 32009: 92010: 22011: 42012: 92013: 92014: 52015: 92016: 32017: 22018: 32019: 52020: 52021: 52022: 22023: 52024: 32025: 22026 (partial year): 3
2007high 9 (2009) · low 2 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTZ

124in 2024

2007: 55 days median2008: 88 days median2009: 210 days median2011: 160 days median2012: 90 days median2013: 28 days median2014: 28 days median2015: 134 days median2016: 62 days median2018: 72 days median2019: 90 days median2020: 93 days median2021: 336 days median2023: 145 days median2024: 124 days median2026 (partial year): 137 days median
2007high 336 (2021) · low 28 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DTZ

1in 2025

2007: 72008: 52010: 12011: 132012: 142014: 22016: 12018: 2, 2 Class I2019: 12020: 32021: 1, 1 Class I2022: 62025: 1
2007high 14 (2012) · low 0 (2009)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · DTZ

976in 2025

2007: 1342008: 1052009: 522010: 1192011: 1902012: 2152013: 3462014: 7642015: 6582016: 4432017: 3882018: 3202019: 4892020: 4422021: 5952022: 5592023: 7382024: 5352025: 976
2007high 976 (2025) · low 52 (2009)2025

MAUDE reports naming product code DTZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074557134
20083885105
20099210052
20102—1119
2011416013190
201299014215
20139280346
20145282764
201591340658
20163621443
20172—0388
20183722 (2)320
20195901489
20205933442
202153361 (1)595
20222—6559
202351450738
202431240535
20252—1976
202631370—

What is it indicated for?

The Dideco Lilliput Ph.I.S.I.0.Membrane Oxygenator is intended for use in ilufancs welghing not more than 8 Kg (17.6 1b.) who underyo cardilopulmondry bypass surgery requiring extracorporeal circulation. It provides oxygenation and carbon dioxide rewmoval from venous blood. The integrated heat exchanger providea hland temperature cantral and allaws the use of hynpothermia ar aids in the waintenance of normotherwia during surgery. The venous reservoir is intended to collect blood during normal operation, to always assure the proper oxygenation capability of the device. The Lilliput Ph.I.S.I.0. should not be used longer than 6 hours. Contact with blood for longer periods is not advised,

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Dideco S.P.A.

22 FDA decisions under this applicant name. See the company

  • K041061D731 Micro 20 and D733 Micro 40 Pediatric Arterial FiltersDideco S.P.A. · 2004
  • K033323D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator with…Dideco S.P.A. · 20041 recall
  • K033987D735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial FiltersDideco S.P.A. · 2004
  • K033714MVR 1200 PC: Sorin Monolyth Venous Reservoir 1200 PC with Phosphorylcholine CoatingDideco S.P.A. · 2003
  • K032040Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult…Dideco S.P.A. · 20031 recall

Recent decisions in DTZ

The DTZ category page

  • K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.L · 2026
  • K253838Lifemotion Disposable Membrane OxygenatorLifemotion Medical Technology Co., Ltd. · 2026
  • K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3…Spectrum Medical S.R.L. · 2026
  • K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus…Eurosets S.R.L · 2025
  • K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.L · 2025

https://510kreport.com/device/K991737 · printed Nov 5, 2026

Cite this page

510(k) Report. “K991737: Lilliput Phospholypidic Inert Surface in Oxygenation (PH.I.S.I.O.) Infant/Newborn Hollow Fiber Oxygenator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991737

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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