510(k) · Cleared

Cleared

Intersept Filtered Cardiotomy Reservoir

K151110510(k) SpecialCleared May 27, 201530-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

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

Cleared on May 27, 2015 after a 30-day review. The FDA summary names its predicate without a number. 1 later device descends from it.

Decided: May 27, 2015
Review: 30 days
Class: Class II
Product code: DTN
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK151110 Intersept Filtered Cardiotomy ReservoirMedtronic, Inc. · 2015
Descendant · cites it directly · 0 of its ownK170583 Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc. · 2017

Most influential descendants

Showing 1 of 1 · See all

K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc. · 2017 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K151110	Intersept Filtered Cardiotomy Reservoir	Medtronic, Inc.	2015	—
+1	K170583	Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface	Medtronic, Inc.	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0

FIG. 1 — Lineage of K151110, 2015–2017Source: 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 12.3 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

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
*	—	Intersept® Cardiotomy Reservoir with Filter Named without a submission number			—

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K170583	Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface	Medtronic, Inc.	2017	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, K170583 (Medtronic, Inc., 2017) 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. 2015, this device’s year, is highlighted.

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 Intersept filtered cardiotomy reservoir is indicated for use in the cardiopulmonary bypass circuit during surgery for:

• an air/fluid separation chamber;

• a temporary storage reservoir for priming solution and blood;

• the filtration of particulates from bank blood and the storage and filtration of blood recovered from the field by suction;

• the addition of medications or other fluids.

The Intersept filtered cardiotomy reservoir is also indicated for use after open heart surgery for:

• the post-operative collection of autologous blood from the chest and the aseptic return of blood to the patient for volume replacement.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K151110 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151110: Intersept Filtered Cardiotomy Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151110

Report an extraction error

Are you the manufacturer?

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