510(k) · Cleared
Recalled · Class II · 2018Arrow M.I.S. Multi-Lumen Catheteriza
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · DQY Catheter, Percutaneous
Cleared on Apr 14, 1982 after a 36-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. It has been recalled 7 times.
- Decided
- Apr 14, 1982
- Review
- 36 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 7
- 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.
- This deviceK820648 Arrow M.I.S. Multi-Lumen CatheterizaArrow Intl., Inc. · 1982
- Descendant · cites it directly · 13 of its ownK970864 Arrow-Howes Large Bore Multi-Lumen Central Venous CathetersArrow Intl., Inc. · 1997 · Recalled (Class I)
- Descendant · 2 generations on · 11 of its ownK014241 Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A…Alsius Corp. · 2003 · Recalled
- Descendant · 3 generations on · 6 of its ownK101987 Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and…Zoll Circulation · 2010
- Descendant · 3 generations on · 4 of its ownK150046 Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter…Zoll Circulation, Inc. · 2015 · Recalled
- 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
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K820648 | Arrow M.I.S. Multi-Lumen Catheteriza | Arrow Intl., Inc. | 1982 | — |
| +1 | K970864 | Arrow-Howes Large Bore Multi-Lumen Central Venous Catheters | Arrow Intl., Inc. | 1997 | Class I |
| +2 | K014241 | Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500D | Alsius Corp. | 2003 | 6 |
| +3 | K101987 | Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro… | Zoll Circulation | 2010 | — |
| +3 | K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY… | Zoll Circulation, Inc. | 2015 | 21 |
| +4 | K141139 | Solex Intravascular Heat Exchange Catheter | Zoll Circulation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 1 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
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 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K970864 | Arrow-Howes Large Bore Multi-Lumen Central Venous Catheters Class I | 1997 | 13 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 11, 2018 | Class II | Z-2007-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-2009-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-2008-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-2006-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Jul 29, 2010 | Not classified | Z-2490-2010 | Mixed-up of materials/components | Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle |
| Jul 29, 2010 | Not classified | Z-2489-2010 | Mixed-up of materials/components | Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle |
| Jul 29, 2010 | Not classified | Z-2492-2010 | Mixed-up of materials/components | Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle |
The 5 latest of 7 recalls; the web page lists all.
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 DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
https://510kreport.com/device/K820648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K820648: Arrow M.I.S. Multi-Lumen Catheteriza.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K820648
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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