510(k) Report

510(k) · Cleared

Cleared

Arrow-Geiss Percutaneous TPN Kit

K844080510(k) TraditionalCleared Apr 17, 1985180-day reviewClass II21 CFR 880.5970

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

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

Cleared on Apr 17, 1985 after a 180-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 15 devices in its family, counting itself, has a Class I recall. 14 later devices descend from it.

Decided
Apr 17, 1985
Review
180 days
Class
Class II
Product code
LJS
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared, 1 with a Class I recall12002: 1 descendant cleared2003: 1 descendant cleared2010: 1 descendant cleared2016: 2 descendants cleared2004: 1 descendant cleared2005: 1 descendant cleared2015: 1 descendant cleared2008: 1 descendant cleared2014: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant cleared2022: 1 descendant cleared1990200020102020
  1. This deviceK844080 Arrow-Geiss Percutaneous TPN KitArrow Intl., Inc. · 1985
  2. Descendant · cites it directly · 13 of its ownK970864 Arrow-Howes Large Bore Multi-Lumen Central Venous CathetersArrow Intl., Inc. · 1997 · Recalled (Class I)
  3. Descendant · 2 generations on · 11 of its ownK014241 Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A…Alsius Corp. · 2003 · Recalled
  4. Descendant · 3 generations on · 6 of its ownK101987 Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and…Zoll Circulation · 2010
  5. Descendant · 3 generations on · 4 of its ownK150046 Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter…Zoll Circulation, Inc. · 2015 · Recalled
  6. Descendant · 4 generations on · 4 of its ownK141139 Solex Intravascular Heat Exchange CatheterZoll Circulation · 2014

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

1997: 12002: 12003: 12004: 12005: 12008: 12010: 12014: 12015: 12016: 22021: 12022: 12023: 1
1997high 2 (2016) · low 0 (1998)2026

Class I recalls in this family

  • K970864 Arrow-Howes Large Bore Multi-Lumen Central…cites it directly · 1997

Most influential descendants

Showing 5 of 14 · See all
  • K970864Arrow-Howes Large Bore Multi-Lumen Central Venous CathetersArrow Intl., Inc. · 1997 · cites it directly13descendants
  • K014241Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500DAlsius Corp. · 2003 · 2 generations on11descendants
  • K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…Zoll Circulation · 2010 · 3 generations on6descendants
  • K150046Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…Zoll Circulation, Inc. · 2015 · 3 generations on4descendants
  • K141139Solex Intravascular Heat Exchange CatheterZoll Circulation · 2014 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K844080Arrow-Geiss Percutaneous TPN KitArrow Intl., Inc.1985—
+1K970864Arrow-Howes Large Bore Multi-Lumen Central Venous CathetersArrow Intl., Inc.1997Class I
+2K014241Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500DAlsius Corp.20036
+3K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro…Zoll Circulation2010—
+3K150046Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY…Zoll Circulation, Inc.201521
+4K141139Solex Intravascular Heat Exchange CatheterZoll Circulation2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199711
200210
200310
200410
200510
200810
201010
201410
201510
201620
202110
202210
202310
FIG. 1 — Lineage of K844080, 1985–2023Source: 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.

1 device in this family has 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
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? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K970864Arrow-Howes Large Bore Multi-Lumen Central Venous Catheters Class IArrow Intl., Inc.199713

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

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.

  • K970864Arrow-Howes Large Bore Multi-Lumen Central Venous CathetersArrow Intl., Inc. · 1997 · Cites it directly · ◆ in the 1997 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K970864 (Arrow Intl., Inc., 1997) has gone furthest, with 13 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 Arrow Intl., Inc.

110 FDA decisions under this applicant name. See the company

  • K100635Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model: S-44041-002…Arrow Intl., Inc. · 2010
  • K093050Arrow Seldinger Arterial Catherization Devices, Models EX Sac 00520Arrow Intl., Inc. · 2009
  • K071491Arrow International, Inc., Surgical DrapesArrow Intl., Inc. · 2007
  • K071998Arrow Echogenic Introducer Needle ComponentArrow Intl., Inc. · 20072 recalls
  • K071111Non-Absorbable Silk SutureArrow Intl., Inc. · 2007

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/K844080 · printed Nov 4, 2026

Cite this page

510(k) Report. “K844080: Arrow-Geiss Percutaneous TPN Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K844080

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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