510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

Non-Sterile,Single/Souble Lumen-Cath

K830233510(k) TraditionalCleared Feb 28, 198334-day reviewClass II21 CFR 880.5970Recalls 3

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

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

Cleared on Feb 28, 1983 after a 34-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled 3 times.

Decided
Feb 28, 1983
Review
34 days
Class
Class II
Product code
LJS
Recalls
3
Predicates
0

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

Descendants, by year cleared 2004: 1 descendant cleared2018: 1 descendant cleared19801990200020102020
  1. This deviceK830233 Non-Sterile,Single/Souble Lumen-CathEvermed, Inc. · 1983
  2. Descendant · cites it directly · 1 of its ownK041088 Trifusion, Model 0609190/0659350C.R. Bard, Inc. · 2004
  3. Descendant · 2 generations on · 0 of its ownK172511 Hickman TriFusion CatheterC.R. Bard, Inc. · 2018

Most influential descendants

Showing 2 of 2 · See all
  • K041088Trifusion, Model 0609190/0659350C.R. Bard, Inc. · 2004 · cites it directly1descendant
  • K172511Hickman TriFusion CatheterC.R. Bard, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K830233Non-Sterile,Single/Souble Lumen-CathEvermed, Inc.1983—
+1K041088Trifusion, Model 0609190/0659350C.R. Bard, Inc.2004—
+2K172511Hickman TriFusion CatheterC.R. Bard, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
201810
FIG. 1 — Lineage of K830233, 1983–2018Source: 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 has not posted a summary or statement for it, 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
K041088Trifusion, Model 0609190/0659350C.R. Bard, Inc.20041

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

Recalls of this device

DateClassRecallRoot causeReason
Dec 12, 2025Class IIZ-1367-2026Process controlDue to damage to outer tray that can potentially compromise the sterile barrier
Feb 21, 2013Class IIZ-0909-2013Mixed-up of materials/componentsBard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer…
Feb 21, 2013Class IIZ-0910-2013Mixed-up of materials/componentsBard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K041088 (C.R. Bard, Inc., 2004) 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 Evermed, Inc.

6 FDA decisions under this applicant name. See the company

  • K840846Sterile Hichman/Broviac Injection CapEvermed, Inc. · 1984
  • K840529Steiger Tunneling Instrument 285Evermed, Inc. · 1984
  • K830256Non-Sterile Broviac Parenteral Alimi-Evermed, Inc. · 19831 recall
  • K830406Non-Sterile Catheter Repair KitsEvermed, Inc. · 19831 recall
  • K830257Non-Sterile Peritoneal Access Cathet-Evermed, Inc. · 1983

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/K830233 · printed Nov 6, 2026

Cite this page

510(k) Report. “K830233: Non-Sterile,Single/Souble Lumen-Cath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K830233

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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