510(k) Report

510(k) · Cleared

Cleared

Dual Lumen L-Cath Catheter System

K925979510(k) TraditionalCleared May 27, 1993183-day reviewClass II21 CFR 870.1330

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

Luther Medical Products, Inc. · DQX Wire, Guide, Catheter

Cleared on May 27, 1993 after a 183-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
May 27, 1993
Review
183 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
0

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

Descendants, by year cleared 2009: 1 descendant cleared2023: 1 descendant cleared1990200020102020
  1. This deviceK925979 Dual Lumen L-Cath Catheter SystemLuther Medical Products, Inc. · 1993
  2. Descendant · cites it directly · 1 of its ownK091670 BD L-Cath Single and Dual Lument Catheters, Midline CatheterBecton, Dickinson & CO · 2009
  3. Descendant · 2 generations on · 0 of its ownK230669 L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline CathetersArgon Medical Devices · 2023 · Recalled

Most influential descendants

Showing 2 of 2 · See all
  • K091670BD L-Cath Single and Dual Lument Catheters, Midline CatheterBecton, Dickinson & CO · 2009 · cites it directly1descendant
  • K230669L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline CathetersArgon Medical Devices · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K925979Dual Lumen L-Cath Catheter SystemLuther Medical Products, Inc.1993—
+1K091670BD L-Cath Single and Dual Lument Catheters, Midline CatheterBecton, Dickinson & CO2009—
+2K230669L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline CathetersArgon Medical Devices20233

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
202310
FIG. 1 — Lineage of K925979, 1993–2023Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DQX? 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 DQX device

  1. #1 K213854 SavvyWirescore 15.7 · 10 generations · 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K091670BD L-Cath Single and Dual Lument Catheters, Midline CatheterBecton, Dickinson & CO20091

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, K091670 (Becton, Dickinson & CO, 2009) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQX

10in 2025

2007: 142008: 192009: 182010: 212011: 182012: 202013: 182014: 182015: 152016: 142017: 192018: 192019: 132020: 142021: 62022: 152023: 102024: 112025: 102026 (partial year): 12
2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007: 85 days median2008: 87 days median2009: 87 days median2010: 63 days median2011: 43 days median2012: 62 days median2013: 119 days median2014: 103 days median2015: 112 days median2016: 179 days median2017: 85 days median2018: 114 days median2019: 173 days median2020: 106 days median2021: 161 days median2022: 212 days median2023: 136 days median2024: 134 days median2025: 177 days median2026 (partial year): 145 days median
2007high 212 (2022) · low 43 (2011)2026

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

Recalls per year · DQX

3in 2024

2007: 122008: 72009: 492010: 342011: 32012: 52013: 7, 4 Class I2015: 12016: 2, 2 Class I2017: 172018: 92019: 22020: 1, 1 Class I2024: 32026 (partial year): 4, 1 Class I
2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007: 7602008: 7152009: 6872010: 9872011: 1,3112012: 1,3372013: 1,4742014: 1,3232015: 1,3232016: 1,4662017: 1,5242018: 1,7372019: 1,6792020: 1,5362021: 1,7132022: 1,6472023: 2,0682024: 2,2102025: 2,178
2007high 2,210 (2024) · low 687 (2009)2025

MAUDE reports naming product code DQX, 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
2007148512760
200819877715
2009188749687
2010216334987
2011184331,311
2012206251,337
2013181197 (4)1,474
20141810301,323
20151511211,323
2016141792 (2)1,466
20171985171,524
20181911491,737
20191317321,679
2020141061 (1)1,536
2021616101,713
20221521201,647
20231013602,068
20241113432,210
20251017702,178
2026121454 (1)—

More from Luther Medical Products, Inc.

17 FDA decisions under this applicant name. See the company

  • K982797Blunt T-Peel Introducer Model Number PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICBLuther Medical Products, Inc. · 1998
  • K980090Onecath, L-Cath Catheter System, Model OC-(16-22 GA., 5CM-60CM)Luther Medical Products, Inc. · 1998
  • K974543L-Cath Modified Seldinger Technique Insertion/Catheter Exchange Kit PE-MST24-24 GA. Kit, L-Cath Modified…Luther Medical Products, Inc. · 1998
  • K940198L-Cath Connector AssemblyLuther Medical Products, Inc. · 1994
  • K942103L-Cath Catheter System - Port L-CathLuther Medical Products, Inc. · 1994

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https://510kreport.com/device/K925979 · printed Nov 4, 2026

Cite this page

510(k) Report. “K925979: Dual Lumen L-Cath Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K925979

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