510(k) · Cleared

Recalled · Class II · 2019

Protek Solo 24 Fr Venous Cannula Set

K162214510(k) TraditionalCleared Nov 30, 2016114-day reviewClass II21 CFR 870.4210Recalls 1

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

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

Cleared on Nov 30, 2016 as substantially equivalent to K133236 (Cardiacassist, Inc., 2014) and 1 other predicate after a 114-day review. Its family tree reaches back 3 generations to 2001. It has been recalled once.

Decided: Nov 30, 2016
Review: 114 days
Class: Class II
Product code: DWF
Recalls: 1
Predicates: 2

Its longest line of descent runs back 3 generations to K003288 (2001). 5 ancestors in all, the oldest K924642 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK003288 Origen Dual Lumen CatheterOrigen Biomedical, Inc. · 2001
2 generations backK081820 Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR…Avalon Laboratories, LLC · 2008
1 generation backK140999 Tandemheart Veno-Venous CannulaCardiacassist, Inc. · 2014
This deviceK162214 Protek Solo 24 Fr Venous Cannula SetCardiacassist, Inc. · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K003288	Origen Dual Lumen Catheter	Origen Biomedical, Inc.	2001	—
−2	K081820	Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR…	Avalon Laboratories, LLC	2008	—
−1	K140999	Tandemheart Veno-Venous Cannula	Cardiacassist, Inc.	2014	—
0 (this device)	K162214	Protek Solo 24 Fr Venous Cannula Set	Cardiacassist, Inc.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
2014	1	0

FIG. 1 — Lineage of K162214, 2001–2016Source: 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 DWF? 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? (2)

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
*	K133236	Tandemheart Femoral Venous Cannula Set Summary page 4 …nary bypass vascular catheter, cannula, or tubing. (21 CFR 870.4210, Product Code DWF) Predicate Device TandemHeart 21 Fr Venous Cannula (K133236) Protek Duo Veno-Venous Cannula Introducer (K140999) Device Description The Protek Solo 24 Fr Venous Cannula Set cons…	Cardiacassist, Inc.	2014	—
*	K140999	Tandemheart Veno-Venous Cannula Summary page 4 …tubing. (21 CFR 870.4210, Product Code DWF) Predicate Device TandemHeart 21 Fr Venous Cannula (K133236) Protek Duo Veno-Venous Cannula Introducer (K140999) Device Description The Protek Solo 24 Fr Venous Cannula Set consists of two components: a 24 Fr single lumen…	Cardiacassist, Inc.	2014	—

Also cleared against K133236: 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)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 19, 2019	Class II	Z-1106-2020	Employee error	The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
1 of the 5 ancestors has a recall of any class.
1 other device also cites its predicate K133236.

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. 2016, this device’s year, is highlighted.

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	—

What is it indicated for?

The Protek Solo 24 Fr Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.

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/K162214 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162214: Protek Solo 24 Fr Venous Cannula Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162214

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