510(k) Report

510(k) · Cleared

Recalled · 2005

L-Cath Peel Away System Catheter

K920755510(k) TraditionalCleared Jun 7, 1993474-day reviewClass II21 CFR 880.5970Recalls 10

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. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Cleared on Jun 7, 1993 after a 474-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it. It has been recalled 10 times.

Decided
Jun 7, 1993
Review
474 days
Class
Class II
Product code
LJS
Recalls
10
Predicates
0

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

Descendants, by year cleared 2009: 1 descendant cleared2004: 1 descendant cleared2013: 1 descendant cleared2023: 1 descendant cleared1990200020102020
  1. This deviceK920755 L-Cath Peel Away System CatheterLuther 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 · cites it directly · 1 of its ownK042461 Kendall Argyle 2 FR Double Lumen Neonatal/Pediatric Picc, Model 43304Kendall · 2004 · Recalled
  4. Descendant · 2 generations on · 0 of its ownK230669 L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline CathetersArgon Medical Devices · 2023 · Recalled
  5. Descendant · 2 generations on · 0 of its ownK132567 Argyle Peripherally Inserted Central Catheter Single Lumen, Argyle…Covidien · 2013

Most influential descendants

Showing 4 of 4 · See all
  • K091670BD L-Cath Single and Dual Lument Catheters, Midline CatheterBecton, Dickinson & CO · 2009 · cites it directly1descendant
  • K042461Kendall Argyle 2 FR Double Lumen Neonatal/Pediatric Picc, Model 43304Kendall · 2004 · cites it directly1descendant
  • K230669L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline CathetersArgon Medical Devices · 2023 · 2 generations on0descendants
  • K132567Argyle Peripherally Inserted Central Catheter Single Lumen, Argyle Peripherally Inserted…Covidien · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K920755L-Cath Peel Away System CatheterLuther Medical Products, Inc.1993—
+1K091670BD L-Cath Single and Dual Lument Catheters, Midline CatheterBecton, Dickinson & CO2009—
+1K042461Kendall Argyle 2 FR Double Lumen Neonatal/Pediatric Picc, Model 43304Kendall20041
+2K230669L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline CathetersArgon Medical Devices20233
+2K132567Argyle Peripherally Inserted Central Catheter Single Lumen, Argyle…Covidien2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200910
201310
202310
FIG. 1 — Lineage of K920755, 1993–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 LJS? 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 LJS device

  1. #1 K241910 Neonav ECG Tip Location Systemscore 18.0 · 12 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? (4)

2 later devices cite 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
K042461Kendall Argyle 2 FR Double Lumen Neonatal/Pediatric Picc, Model 43304Kendall20041

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 25, 2005Not classifiedZ-0286-06OtherAspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
Mar 25, 2005Not classifiedZ-0283-06OtherAspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
Mar 25, 2005Not classifiedZ-0288-06OtherAspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
Mar 25, 2005Not classifiedZ-0282-06OtherAspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
Mar 25, 2005Not classifiedZ-0284-06OtherAspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
Mar 25, 2005Not classifiedZ-0285-06OtherAspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
Mar 25, 2005Not classifiedZ-0287-06OtherAspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
Mar 9, 2004Not classifiedZ-0785-04OtherCatheters have stylets extending past the catheter tip, which, if not noticed could cause injury upon insertion.
Mar 9, 2004Not classifiedZ-0783-04OtherCatheters have stylets extending past the catheter tip, which, if not noticed could cause injury upon insertion.
Mar 9, 2004Not classifiedZ-0784-04OtherCatheters have stylets extending past the catheter tip, which, if not noticed could cause injury upon insertion.

The 5 latest of 10 recalls; the web page lists all.

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 LJS devices

LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LJS

8in 2025

2007: 142008: 42009: 162010: 92011: 62012: 142013: 142014: 82015: 72016: 92017: 72018: 102020: 22021: 32022: 32023: 42024: 12025: 82026 (partial year): 2
2007high 16 (2009) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJS

171in 2025

2007: 92 days median2008: 97 days median2009: 70 days median2010: 114 days median2011: 55 days median2012: 77 days median2013: 31 days median2014: 47 days median2015: 71 days median2016: 128 days median2017: 101 days median2018: 148 days median2021: 284 days median2022: 177 days median2023: 47 days median2025: 171 days median
2007high 284 (2021) · low 31 (2013)2026

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

Recalls per year · LJS

5in 2023

2008: 12009: 12010: 122011: 42012: 402014: 152015: 22016: 182017: 92018: 32021: 12023: 5, 2 Class I2026 (partial year): 8, 1 Class I
2007high 40 (2012) · low 0 (2007)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · LJS

4,372in 2025

2007: 3922008: 3692009: 3792010: 4952011: 6962012: 5642013: 6802014: 8422015: 1,3062016: 1,1232017: 2,1002018: 2,3242019: 2,0522020: 2,5392021: 3,0842022: 3,2562023: 2,7992024: 4,2432025: 4,372
2007high 4,372 (2025) · low 369 (2008)2025

MAUDE reports naming product code LJS, 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
200714920392
20084971369
200916701379
2010911412495
20116554696
2012147740564
201314310680
201484715842
201577121,306
20169128181,123
2017710192,100
20181014832,324
20190—02,052
20202—02,539
2021328413,084
2022317703,256
20234475 (2)2,799
20241—04,243
2025817104,372
20262—8 (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

Recent decisions in LJS

The LJS category page

  • K260080Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL TunnelerMedical Components, Inc. · 2026
  • K260929Neonav ECG Tip Location SystemNavi Medical Technologies · 2026
  • K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and…Spectrum Vascular · 2025
  • K252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc. · 2025
  • K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single…Access Vascular, Inc. · 2025

https://510kreport.com/device/K920755 · printed Nov 5, 2026

Cite this page

510(k) Report. “K920755: L-Cath Peel Away System Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K920755

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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