510(k) · Cleared

Cleared

Venomidicard Pediatric Venous Reservoir with Integralcardiotomy Filter/Midicard Pediatric Cardiotomy Reservoir with Filt

K964907510(k) TraditionalCleared Aug 21, 1997255-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

Sorin Biomedical, Inc. · DTN Reservoir, Blood, Cardiopulmonary Bypass

Cleared on Aug 21, 1997 as substantially equivalent to K872719 (Shiley, Inc., 1987) after a 255-day review. Its family tree reaches back 1 generation to 1987.

Decided: Aug 21, 1997
Review: 255 days
Class: Class II
Product code: DTN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K872719 (1987). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK872719 Expanded Use of Hardshell Venous Reserv. W/FilterShiley, Inc. · 1987
This deviceK964907 Venomidicard Pediatric Venous Reservoir with Integralcardiotomy…Sorin Biomedical, Inc. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K872719	Expanded Use of Hardshell Venous Reserv. W/Filter	Shiley, Inc.	1987	—
0 (this device)	K964907	Venomidicard Pediatric Venous Reservoir with Integralcardiotomy…	Sorin Biomedical, Inc.	1997	—

FIG. 1 — Lineage of K964907, 1987–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DTN? 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

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K872719	Expanded Use of Hardshell Venous Reserv. W/Filter Summary page 2 …use, materials, design, and performance characteristics to the Sorin Hardshell Venous Reservoir (HSVRF). The HSVRF was cleared for chest drainage on September 30, 1987 (K872719). These device were designed for use in chest drainage and are marketed by DIDECO for that intended use outside the United States…	Shiley, Inc.	1987	—

Also cleared against K872719: 1 other device →

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?

Its one ancestor has no recall.
1 other device also cites its predicate K872719.

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

2007high 7 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTN

38in 2014

2007high 211 (2009) · low 38 (2014)2026

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

Recalls per year · DTN

2in 2018

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

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

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 Dideco Venomidicard and Midicard are hardshell blood collection

reservoirs intended for use in CPB circuits and postoperative blood

salvage procedures.

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

https://510kreport.com/device/K964907 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964907: Venomidicard Pediatric Venous Reservoir with Integralcardiotomy Filter/Midicard Pediatric Cardiotomy Reservoir with Filt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964907

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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