510(k) Report

510(k) · Cleared

Recalled · Class I · 2026

Arrow-Howes Large Bore Multi-Lumen Central Venous Catheters

K970864510(k) TraditionalCleared Oct 17, 1997221-day reviewClass II21 CFR 880.5200Recalls 4 (1 Class I)

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

Arrow Intl., Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Cleared on Oct 17, 1997 as substantially equivalent to K820648 (Arrow Intl., Inc., 1982) and 3 other predicates after a 221-day review. Its family tree reaches back 1 generation to 1982. 3 of the 18 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it. It has been recalled 4 times, including a Class I recall.

Decided
Oct 17, 1997
Review
221 days
Class
Class II
Product code
FOZ
Recalls
4 (1 Class I)
Predicates
4

Its longest line of descent runs back 1 generation to K820648 (1982). 4 ancestors in all. 13 later devices descend from it, 2 citing it directly. 3 of the 18 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1990: 1 other ancestor, 1 with a Class I recall11986: 1 other ancestor, 1 with a Class I recall11985: 1 other ancestor2002: 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 clearedK820648 · Arrow M.I.S. Multi-Lumen Catheteriza · Arrow Intl., Inc. · 1982 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors, 2 with a Class I recall2 1 generation forward: 2 descendants2 generations forward: 5 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants K820648 · Arrow M.I.S. Multi-Lumen Catheteriza · Arrow Intl., Inc. · 1982 · recalled0
  1. Root · 1 generation backK820648 Arrow M.I.S. Multi-Lumen CatheterizaArrow Intl., Inc. · 1982 · Recalled
  2. This deviceK970864 Arrow-Howes Large Bore Multi-Lumen Central Venous CathetersArrow Intl., Inc. · 1997
  3. Descendant · cites it directly · 11 of its ownK014241 Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A…Alsius Corp. · 2003 · Recalled
  4. Descendant · 2 generations on · 6 of its ownK101987 Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and…Zoll Circulation · 2010
  5. Descendant · 2 generations on · 4 of its ownK150046 Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter…Zoll Circulation, Inc. · 2015 · Recalled
  6. Descendant · 3 generations on · 4 of its ownK141139 Solex Intravascular Heat Exchange CatheterZoll Circulation · 2014
  7. Descendant · 2 generations on · 3 of its ownK153226 Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitZoll Circulation, Inc. · 2016 · Recalled

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12004: 12005: 12008: 12010: 12014: 12015: 12016: 22021: 12022: 12023: 1
2002high 2 (2016) · low 0 (2006)2026

Class I recalls in this family

  • K895417 Arrow Large-Bore Dual Lumen Hemodialysis Kitdirect predicate · 1990
  • K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tipdirect predicate · 1986

Most influential descendants

Showing 5 of 13 · See all
  • K014241Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500DAlsius Corp. · 2003 · cites it directly11descendants
  • K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…Zoll Circulation · 2010 · 2 generations on6descendants
  • K150046Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…Zoll Circulation, Inc. · 2015 · 2 generations on4descendants
  • K141139Solex Intravascular Heat Exchange CatheterZoll Circulation · 2014 · 3 generations on4descendants
  • K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitZoll Circulation, Inc. · 2016 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K820648Arrow M.I.S. Multi-Lumen CatheterizaArrow Intl., Inc.19827
0 (this device)K970864Arrow-Howes Large Bore Multi-Lumen Central Venous CathetersArrow Intl., Inc.1997—
+1K014241Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500DAlsius Corp.20036
+2K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro…Zoll Circulation2010—
+2K150046Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY…Zoll Circulation, Inc.201521
+3K141139Solex Intravascular Heat Exchange CatheterZoll Circulation2014—
+2K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitZoll Circulation, Inc.20164

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198611
199011

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200410
200510
200810
201010
201410
201510
201620
202110
202210
202310
FIG. 1 — Lineage of K970864, 1982–2023Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

3 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 FOZ device

  1. #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 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? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K820648Arrow M.I.S. Multi-Lumen Catheteriza
Summary page 1
…eter, intravascular, BOFOZ, and 21 CFR 880.5200, Name - Intravascular catheter Lega ted device i vice is tanti { t: Various Arrow central venous catheters; specifically K820648, K844080, K862056, and K895417 Description of device: The device is a triple-lumen polyurethane catheter, 12 French in size, wi…
Arrow Intl., Inc.19827
*K844080Arrow-Geiss Percutaneous TPN Kit
Summary page 1
…ravascular, BOFOZ, and 21 CFR 880.5200, Name - Intravascular catheter Lega ted device i vice is tanti { t: Various Arrow central venous catheters; specifically K820648, K844080, K862056, and K895417 Description of device: The device is a triple-lumen polyurethane catheter, 12 French in size, with three…
Arrow Intl., Inc.1985—
*K862056[Central Venous][Multi-Lumen] Catheter W/Flex Tip
Summary page 1
…r, BOFOZ, and 21 CFR 880.5200, Name - Intravascular catheter Lega ted device i vice is tanti { t: Various Arrow central venous catheters; specifically K820648, K844080, K862056, and K895417 Description of device: The device is a triple-lumen polyurethane catheter, 12 French in size, with three extension…
Arrow Intl., Inc.1986Class I
*K895417Arrow Large-Bore Dual Lumen Hemodialysis Kit
Summary page 1
…21 CFR 880.5200, Name - Intravascular catheter Lega ted device i vice is tanti { t: Various Arrow central venous catheters; specifically K820648, K844080, K862056, and K895417 Description of device: The device is a triple-lumen polyurethane catheter, 12 French in size, with three extension lines, fuer…
Arrow Intl., Inc.1990Class I

What descends from it? (13)

See all 13

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K014241Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500DAlsius Corp.200311
K013182Triple Lumen Central Venous CatheterCook, Inc.20020

Has anything in its family been recalled? (3 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 21, 2026Class IZ-2376-2026Nonconforming Material/ComponentLidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a…
May 5, 2022Class IIZ-1290-2022Error in labelingGravity flow rates on the affected product lidstock are incorrect.
May 8, 2009Not classifiedZ-1672-2009Nonconforming Material/ComponentWire guide can have difficulty passing through catheter juncture hub or being removed from the catheter.
May 8, 2009Not classifiedZ-1671-2009Nonconforming Material/ComponentWire guide can have difficulty passing through catheter juncture hub or being removed from the catheter.

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.

  • K895417Arrow Large-Bore Dual Lumen Hemodialysis KitArrow Intl., Inc. · 1990 · Direct predicate · ◆ in the 1990 ancestors bar of FIG. 11 Class I recall
  • K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · Direct predicate · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • 3 of the 4 ancestors have a recall of any class; 2 have a Class I recall.
  • Of its descendants, K014241 (Alsius Corp., 2003) has gone furthest, with 11 descendants of its own.

How does its category compare?

All FOZ devices

FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FOZ

11in 2025

2007: 62008: 92009: 92010: 32011: 62012: 132013: 42014: 92015: 102016: 92017: 92018: 12019: 82020: 102021: 42022: 82023: 92024: 62025: 112026 (partial year): 7
2007high 13 (2012) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FOZ

91in 2025

2007: 159 days median2008: 103 days median2009: 30 days median2010: 28 days median2011: 132 days median2012: 122 days median2013: 104 days median2014: 99 days median2015: 107 days median2016: 63 days median2017: 51 days median2019: 140 days median2020: 191 days median2021: 242 days median2022: 183 days median2023: 129 days median2024: 190 days median2025: 91 days median2026 (partial year): 203 days median
2007high 242 (2021) · low 28 (2010)2026

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

Recalls per year · FOZ

4in 2023

2007: 162009: 232010: 1152013: 22014: 42016: 3, 1 Class I2017: 222018: 42019: 32020: 32021: 12022: 4, 2 Class I2023: 4, 2 Class I2026 (partial year): 2
2007high 115 (2010) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · FOZ

5,110in 2025

2007: 3742008: 4222009: 5082010: 3702011: 7862012: 5602013: 6402014: 8152015: 7292016: 9252017: 1,9662018: 3,3052019: 4,3652020: 3,7972021: 4,6742022: 4,1332023: 4,4302024: 4,7722025: 5,110
2007high 5,110 (2025) · low 370 (2010)2025

MAUDE reports naming product code FOZ, 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
2007615916374
200891030422
200993023508
2010328115370
201161320786
2012131220560
201341042640
20149994815
2015101070729
20169633 (1)925
2017951221,966
20181—43,305
2019814034,365
20201019133,797
2021424214,674
202281834 (2)4,133
202391294 (2)4,430
2024619004,772
2025119105,110
202672032—

What is it indicated for?

The large-bore multiple lumen catheter permits venous access to a central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, and femoral veins. The heparin coating on the catheter intended to decrease the incidence of thrombus formation associated with catheterization.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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 FOZ

The FOZ category page

  • K260432Ruby Intravascular CatheterVenocare, Inc. · 2026
  • K260165Unimpregnated Central Venous CatheterSpectrum Vascular · 2026
  • K261041ClearSafe Closed SystemMedSource Labs, LLC · 2026
  • K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC · 2026
  • K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc. · 2026

https://510kreport.com/device/K970864 · printed Nov 6, 2026

Cite this page

510(k) Report. “K970864: Arrow-Howes Large Bore Multi-Lumen Central Venous Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970864

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026