510(k) · Cleared

Recalled · 2011

Venous Return Catheter SS-1

K845045510(k) TraditionalCleared Apr 3, 198596-day reviewClass II21 CFR 870.4210Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dlp, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Apr 3, 1985 after a 96-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 19 devices in its family, counting itself, have a Class I recall. 18 later devices descend from it. It has been recalled 3 times.

Decided: Apr 3, 1985
Review: 96 days
Class: Class II
Product code: DWF
Recalls: 3
Predicates: 0

18 later devices descend from it, 4 citing it directly. 2 of the 19 devices in this family, counting this one, have a Class I recall.

This deviceK845045 Venous Return Catheter SS-1Dlp, Inc. · 1985
Descendant · cites it directly · 15 of its ownK031827 Ultraflex Venous Cannula, Model 970XX and CB970XXMedtronic Perfusion Systems · 2003
Descendant · 2 generations on · 8 of its ownK052081 Remote Access Perfusion (Rap) Femoral Venous CannulaEstech, Inc. · 2005 · Recalled
Descendant · cites it directly · 7 of its ownK022272 Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total…Medtronic Cardiac Surgical Products · 2003 · Recalled
Descendant · 3 generations on · 6 of its ownK060101 Estech Aortic Easy Flow CannulaEndoscopic Technologies, Inc. · 2006
Descendant · 2 generations on · 6 of its ownK033264 Malleable Single Stage Venous Cannula with Carmeda Bioactive…Medtronic Perfusion Systems · 2003 · Recalled

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2003high 3 (2003) · low 0 (2004)2026

Class I recalls in this family

K102726 Cardiohelp System5 generations on · 2011
K133598 Cardiohelp System6 generations on · 2014

Most influential descendants

Showing 5 of 18 · See all

K031827Ultraflex Venous Cannula, Model 970XX and CB970XXMedtronic Perfusion Systems · 2003 · cites it directly15descendants
K052081Remote Access Perfusion (Rap) Femoral Venous CannulaEstech, Inc. · 2005 · 2 generations on8descendants
K022272Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes)Medtronic Cardiac Surgical Products · 2003 · cites it directly7descendants
K060101Estech Aortic Easy Flow CannulaEndoscopic Technologies, Inc. · 2006 · 3 generations on6descendants
K033264Malleable Single Stage Venous Cannula with Carmeda Bioactive Surface, Model CB681XX SeriesMedtronic Perfusion Systems · 2003 · 2 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K845045	Venous Return Catheter SS-1	Dlp, Inc.	1985	—
+1	K031827	Ultraflex Venous Cannula, Model 970XX and CB970XX	Medtronic Perfusion Systems	2003	—
+2	K052081	Remote Access Perfusion (Rap) Femoral Venous Cannula	Estech, Inc.	2005	1
+1	K022272	Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes)	Medtronic Cardiac Surgical Products	2003	3
+3	K060101	Estech Aortic Easy Flow Cannula	Endoscopic Technologies, Inc.	2006	—
+2	K033264	Malleable Single Stage Venous Cannula with Carmeda Bioactive Surface, Model…	Medtronic Perfusion Systems	2003	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	3	0
2005	1	0
2006	1	0
2009	2	0
2011	2	1
2012	1	0
2013	1	0
2014	2	1
2025	3	0
2026	2	0

FIG. 1 — Lineage of K845045, 1985–2026Source: 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.

2 devices in this family have a Class I recall. 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 DWF device

#1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 8 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?

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

What descends from it? (18)

See all 18

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

Number	Device	Applicant	Decided	Descendants
K031827	Ultraflex Venous Cannula, Model 970XX and CB970XX	Medtronic Perfusion Systems	2003	15
K022272	Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes)	Medtronic Cardiac Surgical Products	2003	7
K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…	Medtronic, Inc.	2011	5
K120988	DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…	Medtronic, Inc.	2012	4

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 14, 2011	Not classified	Z-0808-2012	Labeling design	Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated…
Dec 14, 2011	Not classified	Z-0812-2012	Labeling design	Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated…
Sep 15, 2004	Not classified	Z-1489-04	Other	Spiral tip from DLP VAD cannula may be loose and potentially detach during use.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 6 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K031827 (Medtronic Perfusion Systems, 2003) has gone furthest, with 15 descendants of its own.

How does its category compare?

All DWF devices

DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWF

4in 2025

2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWF

89in 2025

2007high 358 (2021) · low 29 (2024)2026

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

Recalls per year · DWF

4in 2024

2007high 37 (2012) · low 0 (2020)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · DWF

1,020in 2025

2007high 1,020 (2025) · low 99 (2009)2025

MAUDE reports naming product code DWF, 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	—	25	121
2008	6	95	25	126
2009	8	148	21	99
2010	3	62	26	197
2011	5	85	13	212
2012	10	110	37	233
2013	9	110	14 (1)	238
2014	14	110	6	325
2015	9	46	3 (1)	218
2016	3	32	3	144
2017	5	127	2 (1)	101
2018	5	30	10	118
2019	3	120	2	179
2020	3	30	0	142
2021	5	358	3	162
2022	2	—	0	276
2023	2	—	0	470
2024	3	29	4	401
2025	4	89	0	1,020
2026	8	81	20	—

https://510kreport.com/device/K845045 · printed Nov 6, 2026

Cite this page

510(k) Report. “K845045: Venous Return Catheter SS-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K845045

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026