510(k) · Cleared
Recalled · Class II · 2016Arrow Fischell Kink Resist Percut Sheath Intro Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · DYB Introducer, Catheter
Cleared on Apr 22, 1993 after a 223-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 14 of the 195 devices in its family, counting itself, have a Class I recall. 194 later devices descend from it. It has been recalled 3 times.
- Decided
- Apr 22, 1993
- Review
- 223 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 3
- Predicates
- 0
194 later devices descend from it, 8 citing it directly. 14 of the 195 devices in this family, counting this one, have a Class I recall.
- This deviceK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993
- Descendant · cites it directly · 103 of its ownK963320 TFX Medical GuidewireTfx Medical Group · 1996
- Descendant · 2 generations on · 89 of its ownK012083 Attain Access 6218 Left-Heart Delivery System, Model 6218Medtronic Vascular · 2001
- Descendant · 3 generations on · 80 of its ownK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- Descendant · cites it directly · 69 of its ownK012812 Carotid Guiding SheathTerumo Medical Corp. · 2001 · Recalled
- Descendant · 2 generations on · 60 of its ownK051601 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2005
Showing 5 of 194 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 194 · See all- K963320TFX Medical GuidewireTfx Medical Group · 1996 · cites it directly103descendants
- K012083Attain Access 6218 Left-Heart Delivery System, Model 6218Medtronic Vascular · 2001 · 2 generations on89descendants
- K01351710600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002 · 3 generations on80descendants
- K012812Carotid Guiding SheathTerumo Medical Corp. · 2001 · cites it directly69descendants
- K051601Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2005 · 2 generations on60descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924607 | Arrow Fischell Kink Resist Percut Sheath Intro Set | Arrow Intl., Inc. | 1993 | — |
| +1 | K963320 | TFX Medical Guidewire | Tfx Medical Group | 1996 | — |
| +2 | K012083 | Attain Access 6218 Left-Heart Delivery System, Model 6218 | Medtronic Vascular | 2001 | — |
| +3 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| +1 | K012812 | Carotid Guiding Sheath | Terumo Medical Corp. | 2001 | 1 |
| +2 | K051601 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 8 | 0 |
| 2005 | 6 | 0 |
| 2006 | 12 | 0 |
| 2007 | 7 | 1 |
| 2008 | 11 | 0 |
| 2009 | 10 | 0 |
| 2010 | 8 | 0 |
| 2011 | 6 | 1 |
| 2012 | 7 | 1 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 9 | 3 |
| 2016 | 9 | 0 |
| 2017 | 5 | 1 |
| 2018 | 10 | 3 |
| 2019 | 5 | 1 |
| 2020 | 7 | 0 |
| 2021 | 9 | 1 |
| 2022 | 4 | 1 |
| 2023 | 5 | 0 |
| 2024 | 7 | 1 |
| 2025 | 11 | 0 |
| 2026 | 9 | 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.
14 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 DYB device
- #1 K251051 AuST Steerable Sheathscore 18.0 · 10 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (194)
See all 1948 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K963320 | TFX Medical Guidewire | 1996 | 103 |
| K012812 | Carotid Guiding Sheath | 2001 | 69 |
| K980385 | Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional… | 1998 | 17 |
| K012854 | Renal Guiding Sheath | 2001 | 8 |
| K964814 | Bipore Accuflex Percutaneous Sheath Introducer | 1997 | 2 |
| K033569 | Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer Sheath | 2004 | 1 |
| K153771 | TXM Guiding Sheath | 2016 | 0 |
| K973007 | Datascope's 10 FR. Flexisheath Percutaneous Introducer | 1997 | 0 |
Has anything in its family been recalled? (14 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 12, 2016 | Class II | Z-1064-2016 | Packaging process control | Arrow has issued a recall for these products due to potential packaging damage. The sterility of the products cannot be guaranteed. If non-sterile product is used there is a potential for infection to occur. |
| Feb 11, 2009 | Not classified | Z-1491-2009 | Device Design | Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism. |
| Oct 22, 2003 | Not classified | Z-0088-04 | Other | package lid identifies the contents incorrectly |
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.
- K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump…Datascope Corp. · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation…Smiths Medical Asd, Inc. · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K150186Chariot Guiding SheathBoston Scientific Corp · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K142829Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification…Cook Incorporated · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 121 Class I recalls
- K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 110 Class I recalls
- K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy…Cook Incorporated · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
- K121611Amplatzer Torqvue FXAga Medical Corporation · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · 6 generations on · ◆ in the 2018 descendants bar of FIG. 127 Class I recalls
- K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · 6 generations on · ◆ in the 2015 descendants bar of FIG. 112 Class I recalls
- K180864WATCHMAN TruSeal Access SystemBoston Scientific · 2018 · 7 generations on · ◆ in the 2018 descendants bar of FIG. 15 Class I recalls
- K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage CaseDatascope Corp. · 2017 · 7 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
- K212228WATCHMAN FXD Curve Access SystemBoston Scientific Corporation · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 13 Class I recalls
Nearest 12 of 14 shown.
Nearest 5 of 14; all are on the web page.
What does this lineage say?
- Of its descendants, K963320 (Tfx Medical Group, 1996) has gone furthest, with 103 descendants of its own.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, 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 | 12 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (21) | — |
https://510kreport.com/device/K924607 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924607: Arrow Fischell Kink Resist Percut Sheath Intro Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924607
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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