510(k) · Cleared

Recalled · Class I · 2013

Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra Large,Models CF26000.CF29000,CF32000,CF35000,CF4000

K022071510(k) TraditionalCleared Feb 14, 2003233-day reviewClass II21 CFR 870.4260Recalls 1 (1 Class I)

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

Embol-X, Inc. · DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

Cleared on Feb 14, 2003 as substantially equivalent to K003992 (Percu Surge, Inc., 2001) and 1 other predicate after a 233-day review. Its family tree reaches back 1 generation to 1982. 1 of the 6 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled once, including a Class I recall.

Decided: Feb 14, 2003
Review: 233 days
Class: Class II
Product code: DTM
Recalls: 1 (1 Class I)
Predicates: 2

Its longest line of descent runs back 1 generation to K820044 (1982). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK820044 Arterial Blood Filter, #AF-1025Bentley Laboratories, Inc. · 1982
This deviceK022071 Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra…Embol-X, Inc. · 2003
Descendant · cites it directly · 2 of its ownK031946 Embol-X Intra-Aortic Filter: Extra-Small, Small, Medium, Large…Edwards Lifesciences, LLC · 2003
Descendant · cites it directly · 1 of its ownK141465 Cardiogard Emboli Protection CannulaCardiogard Medical, Ltd. · 2015
Descendant · 2 generations on · 0 of its ownK182302 CardioGard Emboli Protection CannulaCardiogard Medical, Ltd. · 2019

Most influential descendants

Showing 3 of 3 · See all

K031946Embol-X Intra-Aortic Filter: Extra-Small, Small, Medium, Large, Extra-LargeEdwards Lifesciences, LLC · 2003 · cites it directly2descendants
K141465Cardiogard Emboli Protection CannulaCardiogard Medical, Ltd. · 2015 · cites it directly1descendant
K182302CardioGard Emboli Protection CannulaCardiogard Medical, Ltd. · 2019 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K820044	Arterial Blood Filter, #AF-1025	Bentley Laboratories, Inc.	1982	—
0 (this device)	K022071	Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra Large,Models…	Embol-X, Inc.	2003	—
+1	K031946	Embol-X Intra-Aortic Filter: Extra-Small, Small, Medium, Large, Extra-Large	Edwards Lifesciences, LLC	2003	—
+1	K141465	Cardiogard Emboli Protection Cannula	Cardiogard Medical, Ltd.	2015	—
+2	K182302	CardioGard Emboli Protection Cannula	Cardiogard Medical, Ltd.	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2015	1	0
2019	1	0

FIG. 1 — Lineage of K022071, 1982–2019Source: 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.

1 device in this family has 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 DTM device

#1 K251744 Affinity Pixie™ Arterial Filter with Balance™…score 11.0 · 2 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? (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
*	K003992	Percusurge Guardwire Temporary Occlusion and Aspiration System Summary page 2 …ity and biocompatibility, and performance to the Medtronic PercuSurge Guardwire Plus Temporary Occlusion and Aspiration System (K003992) and/or the Edwards Lifesciences AF- 1025D/AF-1040D Duraflo (heparin treated) Arterial…	Percu Surge, Inc.	2001	—
*	K820044	Arterial Blood Filter, #AF-1025 Summary page 2 …Aspiration System (K003992) and/or the Edwards Lifesciences AF- 1025D/AF-1040D Duraflo (heparin treated) Arterial Blood Filter (K820044). Technological The EMB0L.X Aortic Filter has similar intended use, design intent, Characteristics: principle of operat…	Bentley Laboratories, Inc.	1982	—

Also cleared against K003992: 2 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K031946	Embol-X Intra-Aortic Filter: Extra-Small, Small, Medium, Large, Extra-Large	Edwards Lifesciences, LLC	2003	2
K141465	Cardiogard Emboli Protection Cannula	Cardiogard Medical, Ltd.	2015	1

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 16, 2013	Class I	Z-0091-2014	Nonconforming Material/Component	Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K031946 (Edwards Lifesciences, LLC, 2003) has gone furthest, with 2 descendants of its own.
2 other devices also cite its predicate K003992.

How does its category compare?

All DTM devices

DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTM

2in 2024

2007high 5 (2009) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTM

246in 2009

2007high 246 (2009) · low 60 (2007)2026

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

Recalls per year · DTM

1in 2019

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DTM

4in 2024

2007high 64 (2014) · low 0 (2009)2025

MAUDE reports naming product code DTM, 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	3	60	0	8
2008	1	—	1	2
2009	5	246	0	0
2010	2	—	0	3
2011	1	—	0	8
2012	2	—	0	6
2013	1	—	0	9
2014	0	—	0	64
2015	0	—	0	34
2016	0	—	0	27
2017	0	—	0	15
2018	0	—	0	23
2019	0	—	1	5
2020	0	—	0	1
2021	0	—	0	1
2022	0	—	0	4
2023	1	—	0	0
2024	2	—	0	4
2025	0	—	0	0
2026	1	—	0	—

What is it indicated for?

The EMBOL-X Aortic Filter is indicated for use with the EMBOL-X Aortic Cannula in cardiac surgery procedures to capture and remove particulate emboli from the ascending aorta and heart during and following cross clamp removal in patients aged 60 years and older undergoing first time non-emergent CABG or isolated aortic or mitral valve repair/replacement.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022071 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022071: Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra Large,Models CF26000.CF29000,CF32000,CF35000,CF4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022071

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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