510(k) Report

510(k) · Cleared

Cleared

Dideco Lilliput 1 Twin Reservoir with Phosphorilcholine Insert Surface in Oxygenation (PH. I.S.I.O.)

K001602510(k) SpecialCleared Jun 8, 200015-day reviewClass II21 CFR 870.4400

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. · DTN Reservoir, Blood, Cardiopulmonary Bypass

Cleared on Jun 8, 2000 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 15 devices in its family, counting itself, has a Class I recall. 14 later devices descend from it.

Decided
Jun 8, 2000
Review
15 days
Class
Class II
Product code
DTN
Recalls
None
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 deviceK001602 Dideco Lilliput 1 Twin Reservoir with Phosphorilcholine Insert…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)K001602Dideco Lilliput 1 Twin Reservoir with Phosphorilcholine Insert Surface in…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 K001602, 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), 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. #1 K251783 Inspire HCR and HCR DUAL cardiotomy reservoirsscore 12.4 · 7 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

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)

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 · 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 DTN devices

DTN Reservoir, Blood, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTN

1in 2025

2007: 22008: 12009: 72010: 12011: 22013: 42014: 32015: 22017: 22023: 12024: 22025: 1
2007high 7 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTN

38in 2014

2009: 211 days median2013: 79 days median2014: 38 days median
2007high 211 (2009) · low 38 (2014)2026

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

Recalls per year · DTN

2in 2018

2007: 12008: 12009: 12011: 12016: 12017: 12018: 2
2007high 2 (2018) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DTN

8in 2025

2007: 102008: 82009: 102010: 182011: 102012: 172013: 472014: 522015: 272016: 62017: 32018: 42019: 112020: 62021: 122022: 72023: 82024: 102025: 8
2007high 52 (2014) · low 3 (2017)2025

MAUDE reports naming product code DTN, 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
20072—110
20081—18
20097211110
20101—018
20112—110
20120—017
2013479047
2014338052
20152—027
20160—16
20172—13
20180—24
20190—011
20200—06
20210—012
20220—07
20231—08
20242—010
20251—08
20260—0—

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 DTN

The DTN category page

  • K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L. · 2025
  • K241206Quantum Perfusion Hybrid SystemSpectrum Medical S.R.L. · 2024
  • K241053MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™…Medtronic Cardiac Surgery · 2024
  • K223361BMR 1900 PhisioSorin Group Italia S.R.L. · 2023
  • K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc. · 2017

https://510kreport.com/device/K001602 · printed Nov 4, 2026

Cite this page

510(k) Report. “K001602: Dideco Lilliput 1 Twin Reservoir with Phosphorilcholine Insert Surface in Oxygenation (PH. I.S.I.O.).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K001602

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026