510(k) Report

510(k) · Cleared

Cleared

Dideco D920, Lilliput 1 Twin Reservoir

K984322510(k) TraditionalCleared Mar 2, 199989-day reviewClass II21 CFR 870.4230

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. · DTP Defoamer, Cardiopulmonary Bypass

Cleared on Mar 2, 1999 as substantially equivalent to K941215 (Sorin Biomedical, Inc., 1995) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 1995.

Decided
Mar 2, 1999
Review
89 days
Class
Class II
Product code
DTP
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K941215 (1995). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestorReference device: K953835 · Lilliput 1 New Born Hollow Fiber Oxygenator · Dideco S.R.L. · 1996K941215 · Venomidicard Infant/ Pediatric Venous Cardiotomy Reservoir · Sorin Biomedical, Inc. · 1995199619982000
Other ancestors, by generation 1 generation back: 1 other ancestor K941215 · Venomidicard Infant/ Pediatric Venous Cardiotomy Reservoir · Sorin Biomedical, Inc. · 19950
  1. Root · 1 generation backK941215 Venomidicard Infant/ Pediatric Venous Cardiotomy ReservoirSorin Biomedical, Inc. · 1995
  2. This deviceK984322 Dideco D920, Lilliput 1 Twin ReservoirDideco S.P.A. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K941215Venomidicard Infant/ Pediatric Venous Cardiotomy ReservoirSorin Biomedical, Inc.1995—
0 (this device)K984322Dideco D920, Lilliput 1 Twin ReservoirDideco S.P.A.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K984322, 1995–1999Source: 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.

Planning a device in DTP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K941215Venomidicard Infant/ Pediatric Venous Cardiotomy Reservoir
Summary page 1
…Venous Cardiotomy Reservoir 6. Predicate Devices 1) VENOMIDICARD/MIDICARD D752/D762 manufactured by: Dideco S.p.A.. Via Statale 12 Nord, 86 41037 Mirandola (MO) ITALY K941215, cleared on May 5, 1995 229 Page 1 2) MICRO SAFE manufactured by: Polystan A/S Walgerholm 8 3500 Vaerlose DENM…
Sorin Biomedical, Inc.1995—
*K953976Safe Micro
Summary page 2
…41037 Mirandola (MO) ITALY K941215, cleared on May 5, 1995 229 Page 1 2) MICRO SAFE manufactured by: Polystan A/S Walgerholm 8 3500 Vaerlose DENMARK K953976, cleared on February 4, 1997 7. Claim of Substantial Equivalence The D 920 is an infant/newborn hard-shell venous reservoir, li…
Polystan A/S1997—
†K953835Lilliput 1 New Born Hollow Fiber OxygenatorDideco S.R.L.1996—

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?

  • None of the 2 ancestors has a recall.

How does its category compare?

All DTP devices

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

FDA decisions per year · DTP

1in 2010

2008: 12010: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTP

Too few DTP 510(k)s in any year since 2007 to give a median.

Recalls per year · DTP

No recall names DTP since 2007.

Adverse event reports per year · DTP

1in 2016

2014: 32016: 1
2007high 3 (2014) · low 0 (2007)2025

MAUDE reports naming product code DTP, 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
20070—00
20081—00
20090—00
20101—00
20110—00
20120—00
20130—00
20140—03
20150—00
20160—01
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Dideco D920, Lilliput 1 twin reservoir is intended for use in infants who underge cardiopulmonary bypass surgery requiring extracorporeal circulation for whom a low circuit priming volume is required. The venous reservoir with cardiotomy filter is intended for use as a storage reservoir (gravity or vacuum-assisted) for venous return blood and as a filtered reservoir for cardiac suction during ECC. The cardiotomy reservoir has the same intended use as…

Read the full statement (108 words)

The Dideco D920, Lilliput 1 twin reservoir is intended for use in infants who underge cardiopulmonary bypass surgery requiring extracorporeal circulation for whom a low circuit priming volume is required. The venous reservoir with cardiotomy filter is intended for use as a storage reservoir (gravity or vacuum-assisted) for venous return blood and as a filtered reservoir for cardiac suction during ECC. The cardiotomy reservoir has the same intended use as the venous reservoir, as a filtered reservoir for cardiac suction blood in a bypass extracorporeal circuit, but does not have a venous return. Following intraoperative use, the reservoirs are used for the collection and autotransfusion of shed blood.

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 DTP

The DTP category page

  • K101186Affinity Vard Sub-Assembly for CPS (Carmeda Coated), Purgeline (Uncoated), Holding BagMedtronic Perfusion Systems · 2010
  • K082412Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating, Model BE-VBT 160, Beq-VBT 160Mapquet Cardiopulmonary AG · 2008
  • K004046Cobe VVR 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt VVR 4000 Filtered Hardshell Venous ReservoirCobe Cardiovascular, Inc. · 2001
  • K002591Cobe Smarxt VVR 4000 Filtered Hardshell Venous ReservoirCobe Cardiovascular, Inc. · 2000
  • K990514Modification of Bard Quantum CVR, Model H-6770VRC.R. Bard, Inc. · 1999

https://510kreport.com/device/K984322 · printed Nov 4, 2026

Cite this page

510(k) Report. “K984322: Dideco D920, Lilliput 1 Twin Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984322

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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