510(k) Report

510(k) · Cleared

Cleared

Endohelix Endarterectomy Device

K032105510(k) TraditionalCleared Oct 30, 2003114-day reviewClass II21 CFR 870.4875

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

Endarx, Inc. · DWX Stripper, Artery, Intraluminal

Cleared on Oct 30, 2003 as substantially equivalent to K904944 (Baxter Healthcare Corp, 1990) and 1 other predicate after a 114-day review. Its family tree reaches back 1 generation to 1990.

Decided
Oct 30, 2003
Review
114 days
Class
Class II
Product code
DWX
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K904944 (1990). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestorK904944 · Transluminal Endarterectomy Device · Baxter Healthcare Corp · 19901990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor K904944 · Transluminal Endarterectomy Device · Baxter Healthcare Corp · 19900
  1. Root · 1 generation backK904944 Transluminal Endarterectomy DeviceBaxter Healthcare Corp · 1990
  2. This deviceK032105 Endohelix Endarterectomy DeviceEndarx, Inc. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K904944Transluminal Endarterectomy DeviceBaxter Healthcare Corp1990—
0 (this device)K032105Endohelix Endarterectomy DeviceEndarx, Inc.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
FIG. 1 — Lineage of K032105, 1990–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 DWX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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.

TypeNumberDeviceApplicantDecidedRecalls
*K904944Transluminal Endarterectomy Device
Summary page 1
…ams President Intended Use The EndoHelix EndarterecLJmyDevice is int nd d to remove plaque deposits from arteries. Predicate Devices K904944 Transluminal Endarterectomy Device from Baxter Healthcare Corporation KO037 19 Periscope Device from Va…
Baxter Healthcare Corp1990—
*K003719Vascular Architects Periscope DeviceVascular Architects, Inc.2001—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • None of the 2 ancestors has a recall.

How does its category compare?

All DWX devices

DWX Stripper, Artery, Intraluminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWX

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWX

Too few DWX 510(k)s in any year since 2007 to give a median.

Recalls per year · DWX

No recall names DWX since 2007.

Adverse event reports per year · DWX

1in 2021

2008: 22009: 12011: 22012: 12017: 12018: 12020: 12021: 1
2007high 2 (2008) · low 0 (2007)2025

MAUDE reports naming product code DWX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—02
20090—01
20100—00
20110—02
20121—01
20130—00
20140—00
20150—00
20160—00
20170—01
20180—01
20190—00
20200—01
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The EndoHelix Endarterectomy Device is intended to remove plaque deposits from arteries.

Indications for use as stated in the FDA summary.

Recent decisions in DWX

The DWX category page

  • K121415Mollring MultitascLeMaitre Vascular, Inc. · 2012
  • K020925Carbodissecting EndoscopeEndo Surgical Devices, Inc. · 2003
  • K003719Vascular Architects Periscope DeviceVascular Architects, Inc. · 2001
  • K950813Mollring CutterCardio Vascular Concepts, Inc. · 1995
  • K933498External Vein StripperApplied Medical Resources · 1994

https://510kreport.com/device/K032105 · printed Nov 3, 2026

Cite this page

510(k) Report. “K032105: Endohelix Endarterectomy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032105

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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