510(k) Report

510(k) · Cleared

Cleared

Lmi Irrigation Catheter (Igr)

K972623510(k) TraditionalCleared Nov 19, 1997128-day reviewClass II21 CFR 870.5150

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

Lucas Medical, Inc. · DXE Catheter, Embolectomy

Cleared on Nov 19, 1997 after a 128-day review. The FDA summary names its predicate without a number. 18 later devices descend from it.

Decided
Nov 19, 1997
Review
128 days
Class
Class II
Product code
DXE
Recalls
None
Predicates
0

18 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2005: 1 descendant cleared2012: 2 descendants cleared2008: 2 descendants cleared2006: 1 descendant cleared2007: 2 descendants cleared2018: 1 descendant cleared2014: 1 descendant cleared2023: 1 descendant cleared2020: 2 descendants cleared2016: 1 descendant cleared2017: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant clearedReference device: K955499 · Lmi Bilumen Irrigation Arterial Embolectomy Cahteter · Lucas Medical, Inc. · 19961995200020052010201520202025
  1. This deviceK972623 Lmi Irrigation Catheter (Igr)Lucas Medical, Inc. · 1997
  2. Descendant · cites it directly · 17 of its ownK041123 Rinspiration System,Rinspiration System Short Tip, Models…Kerberos Proximal Solutions, Inc. · 2004
  3. Descendant · 2 generations on · 16 of its ownK050130 Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005
  4. Descendant · 3 generations on · 9 of its ownK062275 Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006
  5. Descendant · 3 generations on · 6 of its ownK080901 Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008
  6. Descendant · 4 generations on · 5 of its ownK113757 Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12006: 12007: 22008: 22012: 22014: 12016: 12017: 12018: 12020: 22023: 12025: 12026: 1
2004high 2 (2007) · low 0 (2009)2026

Most influential descendants

Showing 5 of 18 · See all
  • K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc. · 2004 · cites it directly17descendants
  • K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005 · 2 generations on16descendants
  • K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006 · 3 generations on9descendants
  • K080901Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008 · 3 generations on6descendants
  • K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K972623Lmi Irrigation Catheter (Igr)Lucas Medical, Inc.1997—
+1K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc.2004—
+2K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc.2005—
+3K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc.2006—
+3K080901Lbi Embolectomy SystemLumen Biomedical, Inc.2008—
+4K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200610
200720
200820
201220
201410
201610
201710
201810
202020
202310
202510
202610
FIG. 1 — Lineage of K972623, 1997–2026Source: 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 DXE? 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 DXE device

  1. #1 K240078 Fogarty Thru-Lumen Embolectomy Catheterscore 7.9 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*—Fogarty Irrigation Catheter
Named without a submission number
—
*—Intimax Irrigating Catheter
Named without a submission number
—
†K955499Lmi Bilumen Irrigation Arterial Embolectomy CahteterLucas Medical, Inc.1996—

What descends from it? (18)

See all 18

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc.200417

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?

  • Of its descendants, K041123 (Kerberos Proximal Solutions, Inc., 2004) has gone furthest, with 17 descendants of its own.

How does its category compare?

All DXE devices

DXE Catheter, Embolectomy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXE

5in 2024

2008: 12010: 22015: 12017: 22020: 12021: 12022: 12024: 5
2007high 5 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXE

173in 2024

2024: 173 days median
2007high 173 (2024)2026

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

Recalls per year · DXE

1in 2023

2007: 32009: 52010: 12011: 12015: 132021: 4, 4 Class I2022: 32023: 12026 (partial year): 2
2007high 13 (2015) · low 0 (2008)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · DXE

306in 2025

2007: 1672008: 1342009: 1242010: 1362011: 1642012: 2002013: 1502014: 1922015: 2662016: 7962017: 7702018: 6152019: 5942020: 5472021: 3332022: 4632023: 4362024: 3772025: 306
2007high 796 (2016) · low 124 (2009)2025

MAUDE reports naming product code DXE, 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—3167
20081—0134
20090—5124
20102—1136
20110—1164
20120—0200
20130—0150
20140—0192
20151—13266
20160—0796
20172—0770
20180—0615
20190—0594
20201—0547
20211—4 (4)333
20221—3463
20230—1436
202451730377
20250—0306
20260—2—

What is it indicated for?

The LMI Irrigation Catheter is intended for intra-operative procedures requiring irrigation in either arterial or venous blood vessels.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Lucas Medical, Inc.

7 FDA decisions under this applicant name. See the company

  • K983802Lmi Carotid Endarterectomy Shunt Catheter, Model #'S Ces, Cesr, Cesb, Cesrb, Cest, Cestr, Cestb, Cestrb…Lucas Medical, Inc. · 1999
  • K970657Lmi Thrombectomy CatheterLucas Medical, Inc. · 1997
  • K955126Lmi Biliary CatheterLucas Medical, Inc. · 1996
  • K954760Lmi Arterial Embolectomy CatheterLucas Medical, Inc. · 1996
  • K955125Lmi Occlusion CatheterLucas Medical, Inc. · 1996

Recent decisions in DXE

The DXE category page

  • K240078Fogarty Thru-Lumen Embolectomy CatheterEdwards Lifesciences, LLC · 2024
  • K241330Fogarty Fortis Arterial Embolectomy CatheterEdwards Lifesciences · 2024
  • K233820Fogarty Arterial Embolectomy Catheter with Gate ValveEdwards Lifesciences · 2024
  • K233819Fogarty Venous Thrombectomy CathetersEdwards Lifesciences, LLC · 2024
  • K233619Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersEdwards Lifesciences · 2024

https://510kreport.com/device/K972623 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972623: Lmi Irrigation Catheter (Igr).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972623

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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