510(k) · Cleared

Cleared

Expanded Use of Hardshell Venous Reserv. W/Filter

K872719510(k) TraditionalCleared Sep 30, 198782-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

Shiley, Inc. · DTN Reservoir, Blood, Cardiopulmonary Bypass

Cleared on Sep 30, 1987 after an 82-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Sep 30, 1987
Review: 82 days
Class: Class II
Product code: DTN
Recalls: None
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK872719 Expanded Use of Hardshell Venous Reserv. W/FilterShiley, Inc. · 1987
Descendant · cites it directly · 0 of its ownK964908 VRF40 Venous Reservoir with Integral Cardiotomy FilterSorin Biomedical, Inc. · 1997
Descendant · cites it directly · 0 of its ownK964907 Venomidicard Pediatric Venous Reservoir with Integralcardiotomy…Sorin Biomedical, Inc. · 1997

Most influential descendants

Showing 2 of 2 · See all

K964908VRF40 Venous Reservoir with Integral Cardiotomy FilterSorin Biomedical, Inc. · 1997 · cites it directly0descendants
K964907Venomidicard Pediatric Venous Reservoir with Integralcardiotomy Filter/Midicard…Sorin Biomedical, Inc. · 1997 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K872719	Expanded Use of Hardshell Venous Reserv. W/Filter	Shiley, Inc.	1987	—
+1	K964908	VRF40 Venous Reservoir with Integral Cardiotomy Filter	Sorin Biomedical, Inc.	1997	—
+1	K964907	Venomidicard Pediatric Venous Reservoir with Integralcardiotomy…	Sorin Biomedical, Inc.	1997	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0

FIG. 1 — Lineage of K872719, 1987–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

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?

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

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K964908	VRF40 Venous Reservoir with Integral Cardiotomy Filter	Sorin Biomedical, Inc.	1997	0
K964907	Venomidicard Pediatric Venous Reservoir with Integralcardiotomy Filter/Midicard…	Sorin Biomedical, Inc.	1997	0

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?

Of its descendants, K964908 (Sorin Biomedical, Inc., 1997) has gone furthest, with 0 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

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	—

https://510kreport.com/device/K872719 · printed Nov 6, 2026

Cite this page

510(k) Report. “K872719: Expanded Use of Hardshell Venous Reserv. W/Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K872719

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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