510(k) Report

510(k) · Cleared

Cleared

Multi-Lumen Central Venous Catheter Set

K904404510(k) TraditionalCleared Feb 15, 1991143-day reviewClass II21 CFR 870.1250

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

Arrow Intl., Inc. · DQY Catheter, Percutaneous

Cleared on Feb 15, 1991 after a 143-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 63 devices in its family, counting itself, has a Class I recall. 62 later devices descend from it.

Decided
Feb 15, 1991
Review
143 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
0

62 later devices descend from it, 3 citing it directly. 1 of the 63 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2003: 4 descendants cleared2002: 1 descendant cleared2004: 3 descendants cleared2007: 3 descendants cleared2006: 1 descendant cleared2008: 4 descendants cleared2009: 1 descendant cleared2005: 2 descendants cleared2019: 1 descendant cleared2023: 2 descendants cleared2010: 3 descendants cleared2011: 2 descendants cleared2016: 3 descendants cleared2014: 5 descendants cleared, 1 with a Class I recall12020: 3 descendants cleared2012: 3 descendants cleared2026: 1 descendant cleared2024: 1 descendant cleared2015: 6 descendants cleared2013: 4 descendants cleared2018: 1 descendant cleared2021: 1 descendant cleared2017: 1 descendant cleared2022: 2 descendants cleared2025: 4 descendants cleared1990200020102020
  1. This deviceK904404 Multi-Lumen Central Venous Catheter SetArrow Intl., Inc. · 1991
  2. Descendant · cites it directly · 33 of its ownK032274 Cook Five Lumen Central Venous CatheterCook, Inc. · 2004
  3. Descendant · 2 generations on · 32 of its ownK060174 Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-AbrmCook, Inc. · 2006
  4. Descendant · 2 generations on · 31 of its ownK081113 Cook and Cook Spectrum Central Venous CathetersCook, Inc. · 2008 · Recalled
  5. Descendant · cites it directly · 27 of its ownK012512 Setpoint Endovascular Temperature Management SystemRadiant Medical · 2002
  6. Descendant · 3 generations on · 26 of its ownK101326 NMI ICNavilyst Medical, Inc. · 2010

Showing 5 of 62 descendants. See all descendants

Descendants cleared per year

2002: 12003: 42004: 32005: 22006: 12007: 32008: 42009: 12010: 32011: 22012: 32013: 42014: 52015: 62016: 32017: 12018: 12019: 12020: 32021: 12022: 22023: 22024: 12025: 42026: 1
2002high 6 (2015) · low 1 (2002)2026

Class I recalls in this family

  • K131260 Nmi Dialysis Catheter5 generations on · 2014

Most influential descendants

Showing 5 of 62 · See all
  • K032274Cook Five Lumen Central Venous CatheterCook, Inc. · 2004 · cites it directly33descendants
  • K060174Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-AbrmCook, Inc. · 2006 · 2 generations on32descendants
  • K081113Cook and Cook Spectrum Central Venous CathetersCook, Inc. · 2008 · 2 generations on31descendants
  • K012512Setpoint Endovascular Temperature Management SystemRadiant Medical · 2002 · cites it directly27descendants
  • K101326NMI ICNavilyst Medical, Inc. · 2010 · 3 generations on26descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K904404Multi-Lumen Central Venous Catheter SetArrow Intl., Inc.1991—
+1K032274Cook Five Lumen Central Venous CatheterCook, Inc.2004—
+2K060174Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-AbrmCook, Inc.2006—
+2K081113Cook and Cook Spectrum Central Venous CathetersCook, Inc.2008105
+1K012512Setpoint Endovascular Temperature Management SystemRadiant Medical2002—
+3K101326NMI ICNavilyst Medical, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200340
200430
200520
200610
200730
200840
200910
201030
201120
201230
201340
201451
201560
201630
201710
201810
201910
202030
202110
202220
202320
202410
202540
202610
FIG. 1 — Lineage of K904404, 1991–2026Source: 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.

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 DQY device

  1. #1 K234115 APRO 55 Catheterscore 17.5 · 6 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? (62)

See all 62

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

NumberDeviceApplicantDecidedDescendants
K032274Cook Five Lumen Central Venous CatheterCook, Inc.200433
K012512Setpoint Endovascular Temperature Management SystemRadiant Medical200227
K024327Setpoint Endovascular Temperature ProbeRadiant Medical20031

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.

  • K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K032274 (Cook, Inc., 2004) has gone furthest, with 33 descendants of its own.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007: 162008: 312009: 372010: 222011: 362012: 302013: 322014: 192015: 272016: 222017: 262018: 252019: 302020: 202021: 182022: 182023: 182024: 162025: 212026 (partial year): 11
2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007: 85 days median2008: 66 days median2009: 73 days median2010: 74 days median2011: 71 days median2012: 87 days median2013: 92 days median2014: 127 days median2015: 118 days median2016: 117 days median2017: 113 days median2018: 106 days median2019: 111 days median2020: 120 days median2021: 81 days median2022: 74 days median2023: 114 days median2024: 87 days median2025: 115 days median2026 (partial year): 30 days median
2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007: 62008: 122009: 172010: 322011: 62012: 22013: 36, 1 Class I2014: 32015: 32016: 22, 7 Class I2017: 82018: 22019: 12020: 22021: 22023: 172024: 12025: 1, 1 Class I2026 (partial year): 2, 1 Class I
2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007: 3132008: 4962009: 8192010: 1,2932011: 1,2112012: 1,1912013: 1,3522014: 1,4972015: 2,3372016: 2,2522017: 2,4892018: 2,8552019: 2,9022020: 2,8892021: 3,0062022: 2,6432023: 3,0492024: 3,1902025: 3,056
2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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
200716856313
2008316612496
2009377317819
20102274321,293
2011367161,211
2012308721,191
2013329236 (1)1,352
20141912731,497
20152711832,337
20162211722 (7)2,252
20172611382,489
20182510622,855
20193011112,902
20202012022,889
2021188123,006
2022187402,643
202318114173,049
2024168713,190
2025211151 (1)3,056
202611302 (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 DQY

The DQY category page

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https://510kreport.com/device/K904404 · printed Nov 4, 2026

Cite this page

510(k) Report. “K904404: Multi-Lumen Central Venous Catheter Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K904404

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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