510(k) · Cleared

Cleared

Maxima Forte Hardshell Venous Reservoir

K961836510(k) TraditionalCleared Nov 1, 1996172-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 Vascular · DTN Reservoir, Blood, Cardiopulmonary Bypass

Cleared on Nov 1, 1996 as substantially equivalent to K933496 (Medtronic Vascular, 1993) and 4 other predicates after a 172-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.

Decided: Nov 1, 1996
Review: 172 days
Class: Class II
Product code: DTN
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K891230 (1989). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK891230 Maxima* Hollow Fiber Oxygenator W/Filtered Reserv.Medtronic Blood Systems, Inc. · 1989
This deviceK961836 Maxima Forte Hardshell Venous ReservoirMedtronic Vascular · 1996
Descendant · cites it directly · 0 of its ownK980935 Capiox SX Hardshell ReservoirTerumo Medical Corp. · 1998

Most influential descendants

Showing 1 of 1 · See all

K980935Capiox SX Hardshell ReservoirTerumo Medical Corp. · 1998 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K891230	Maxima* Hollow Fiber Oxygenator W/Filtered Reserv.	Medtronic Blood Systems, Inc.	1989	—
0 (this device)	K961836	Maxima Forte Hardshell Venous Reservoir	Medtronic Vascular	1996	—
+1	K980935	Capiox SX Hardshell Reservoir	Terumo Medical Corp.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	3	0
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K961836, 1989–1998Source: 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? (5)

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
*	K933496	Maxima Filtered Hardshell Reservior Summary page 1 …r (FT-HSVR) CLASSIFICATION NAME Reservoir, Blood, Cardiopulmonary Bypass NAME OF PREDICATE OR LEGALLY MARKETED DEVICE e Medtronic MAXIMA® Hardshell Venous Reservoir (K933496) e Medtronic MAXIMA® Filtered Hardshell Venous Reservoir (K891230 and K932254) e Terumo Medical Corporation CAPIOX SX Hardshell…	Medtronic Vascular	1993	—
*	K891230	Maxima* Hollow Fiber Oxygenator W/Filtered Reserv. Summary page 1 …Bypass NAME OF PREDICATE OR LEGALLY MARKETED DEVICE e Medtronic MAXIMA® Hardshell Venous Reservoir (K933496) e Medtronic MAXIMA® Filtered Hardshell Venous Reservoir (K891230 and K932254) e Terumo Medical Corporation CAPIOX SX Hardshell Venous Reservoir (K922799) e Avecor Cardiovascular AFFINITY CVR C…	Medtronic Blood Systems, Inc.	1989	—
*	K932254	Maxima Filtered Hardshell Reservoir Summary page 1 …E OF PREDICATE OR LEGALLY MARKETED DEVICE e Medtronic MAXIMA® Hardshell Venous Reservoir (K933496) e Medtronic MAXIMA® Filtered Hardshell Venous Reservoir (K891230 and K932254) e Terumo Medical Corporation CAPIOX SX Hardshell Venous Reservoir (K922799) e Avecor Cardiovascular AFFINITY CVR Cardiotomy/Ve…	Medtronic Vascular	1993	—
*	K922799	Capiox SX Hollow Fiber Oxygenator Summary page 1 …us Reservoir (K933496) e Medtronic MAXIMA® Filtered Hardshell Venous Reservoir (K891230 and K932254) e Terumo Medical Corporation CAPIOX SX Hardshell Venous Reservoir (K922799) e Avecor Cardiovascular AFFINITY CVR Cardiotomy/Venous Hardshell Reservoir (K936003) 510(k) Notification (K961836) MAXIMA FORT…	Terumo Medical Corp.	1993	—
*	K936003	Affinity CVR Summary page 1 …30 and K932254) e Terumo Medical Corporation CAPIOX SX Hardshell Venous Reservoir (K922799) e Avecor Cardiovascular AFFINITY CVR Cardiotomy/Venous Hardshell Reservoir (K936003) 510(k) Notification (K961836) MAXIMA FORTE™ Hardshell Venous Reservoir Confidential Medtronic, Inc. Addendum I Appendix V Medtr…	Avecor Cardiovascular, Inc.	1994	3

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
K980935	Capiox SX Hardshell Reservoir	Terumo Medical Corp.	1998	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?

1 of the 5 ancestors has a recall of any class.
Of its descendants, K980935 (Terumo Medical Corp., 1998) 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	—

What is it indicated for?

The MAXIMA FORTE™ Hardshell Venous Reservoir is intended for use in procedures requiring the storage and filtration of blood in the extracorporeal circuit during cardiopulmonary bypass. The MAXIMA FORTE™ Hardshell Venous Reservoir is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically rcturn the blood to the patient for volume replacement.

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/K961836 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961836: Maxima Forte Hardshell Venous Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961836

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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