510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

Non-Sterile Broviac Parenteral Alimi-

K830256510(k) TraditionalCleared Mar 1, 198335-day reviewClass II21 CFR 880.5970Recalls 1

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 Mar 1, 1983 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 of the 129 devices in its family, counting itself, have a Class I recall. 128 later devices descend from it. It has been recalled once.

Decided
Mar 1, 1983
Review
35 days
Class
Class II
Product code
LJS
Recalls
1
Predicates
0

128 later devices descend from it, 1 citing it directly. 15 of the 129 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2005: 3 descendants cleared2006: 3 descendants cleared2010: 6 descendants cleared, 1 with a Class I recall12009: 7 descendants cleared2007: 7 descendants cleared, 1 with a Class I recall12008: 2 descendants cleared2011: 4 descendants cleared2016: 13 descendants cleared, 2 with a Class I recall22012: 16 descendants cleared, 3 with a Class I recall32019: 4 descendants cleared2015: 7 descendants cleared, 2 with a Class I recall22021: 1 descendant cleared, 1 with a Class I recall12014: 12 descendants cleared, 2 with a Class I recall22013: 13 descendants cleared, 2 with a Class I recall22018: 8 descendants cleared2020: 6 descendants cleared2023: 3 descendants cleared2017: 4 descendants cleared2025: 6 descendants cleared2022: 3 descendants cleared, 1 with a Class I recall119801990200020102020
  1. This deviceK830256 Non-Sterile Broviac Parenteral Alimi-Evermed, Inc. · 1983
  2. Descendant · cites it directly · 127 of its ownK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
  3. Descendant · 2 generations on · 126 of its ownK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
  4. Descendant · 2 generations on · 119 of its ownK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
  5. Descendant · 3 generations on · 66 of its ownK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
  6. Descendant · 2 generations on · 47 of its ownK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006

Showing 5 of 128 descendants. See all descendants

Descendants cleared per year

2005: 32006: 32007: 72008: 22009: 72010: 62011: 42012: 162013: 132014: 122015: 72016: 132017: 42018: 82019: 42020: 62021: 12022: 32023: 32025: 6
2005high 16 (2012) · low 0 (2024)2026

Class I recalls in this family

  • K071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus…3 generations on · 2007
  • K210264 BD PowerPiCC Catheter4 generations on · 2021
  • K113277 Arrowadvantages Pressure Injectable Peripherally…4 generations on · 2012
  • K143102 Multi-Lumen Acute Hemodialysis Catheter for High…4 generations on · 2015

Most influential descendants

Showing 5 of 128 · See all
  • K050185Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005 · cites it directly127descendants
  • K0514176 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · 2 generations on126descendants
  • K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc. · 2005 · 2 generations on119descendants
  • K0709964 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007 · 3 generations on66descendants
  • K061179Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006 · 2 generations on47descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K830256Non-Sterile Broviac Parenteral Alimi-Evermed, Inc.1983—
+1K050185Powerhohn and Powerline CathetersC.R. Bard, Inc.2005—
+2K0514176 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc.20051
+2K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc.2005—
+3K0709964 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc.2007—
+2K061179Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200530
200630
200771
200820
200970
201061
201140
2012163
2013132
2014122
201572
2016132
201740
201880
201940
202060
202111
202231
202330
202560
FIG. 1 — Lineage of K830256, 1983–2025Source: 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.

15 devices in this family have a Class I recall. 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
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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? (128)

See all 128

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

NumberDeviceApplicantDecidedDescendants
K050185Powerhohn and Powerline CathetersC.R. Bard, Inc.2005127

Has anything in its family been recalled? (15 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

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 15 Class I recalls
  • K210264BD PowerPiCC CatheterBard Access Systems, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
  • K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
  • K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
  • K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
  • K102605Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 125 Class I recalls
  • K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
  • K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
  • K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
  • K141531Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc. · 2015 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
  • K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
  • K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall

Nearest 12 of 15 shown.

Nearest 5 of 15; all are on the web page.

What does this lineage say?

  • Of its descendants, K050185 (C.R. Bard, Inc., 2005) has gone furthest, with 127 descendants 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
  • K830406Non-Sterile Catheter Repair KitsEvermed, Inc. · 19831 recall
  • K830233Non-Sterile,Single/Souble Lumen-CathEvermed, Inc. · 19833 recalls
  • 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/K830256 · printed Nov 6, 2026

Cite this page

510(k) Report. “K830256: Non-Sterile Broviac Parenteral Alimi-.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K830256

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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