510(k) · Cleared
Recalled · Class I · 2025Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · DYB Introducer, Catheter
Cleared on Jul 28, 2015 as substantially equivalent to K091329 (Terumo Medical Corp., 2009) and 1 other predicate after a 301-day review. Its family tree reaches back 5 generations to 1993. 1 of the 20 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it. It has been recalled 26 times, including 21 Class I recalls.
- Decided
- Jul 28, 2015
- Review
- 301 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 26 (21 Class I)
- Predicates
- 2
Its longest line of descent runs back 5 generations to K924607 (1993). 6 ancestors in all. 13 later devices descend from it, 3 citing it directly. 1 of the 20 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
- 4 generations backK012812 Carotid Guiding SheathTerumo Medical Corp. · 2001 · Recalled
- 3 generations backK051601 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2005
- 2 generations backK080415 Device Modification to Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2008
- 1 generation backK091329 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2009 · Recalled
- This deviceK142829 Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor…Cook Incorporated · 2015
- Descendant · cites it directly · 6 of its ownK152913 GORE TIPS Set, GORE TIPS Sheath, GORE TIPS NeedleCreganna Medical Aslo Business AS Cregganna Tactx Medical · 2016 · Recalled
- Descendant · 2 generations on · 5 of its ownK171820 Transjugular Liver Access SetsCook Incorporated · 2018 · Recalled
- Descendant · cites it directly · 4 of its ownK152225 Edwards eSheath Introducer SetEdwards Lifesciences · 2015
- Descendant · 2 generations on · 3 of its ownK162184 Edwards eSheath Introducer SetEdward Lifesciences · 2016
- Descendant · 2 generations on · 2 of its ownK200258 Edwards eSheath Introducer SetEdwards Lifesciences · 2020
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
2015high 3 (2021) · low 0 (2017)2026
Most influential descendants
Showing 5 of 13 · See all- K152913GORE TIPS Set, GORE TIPS Sheath, GORE TIPS NeedleCreganna Medical Aslo Business AS Cregganna Tactx Medical · 2016 · cites it directly6descendants
- K171820Transjugular Liver Access SetsCook Incorporated · 2018 · 2 generations on5descendants
- K152225Edwards eSheath Introducer SetEdwards Lifesciences · 2015 · cites it directly4descendants
- K162184Edwards eSheath Introducer SetEdward Lifesciences · 2016 · 2 generations on3descendants
- K200258Edwards eSheath Introducer SetEdwards Lifesciences · 2020 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K924607 | Arrow Fischell Kink Resist Percut Sheath Intro Set | Arrow Intl., Inc. | 1993 | 3 |
| −4 | K012812 | Carotid Guiding Sheath | Terumo Medical Corp. | 2001 | 1 |
| −3 | K051601 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2005 | — |
| −2 | K080415 | Device Modification to Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2008 | — |
| −1 | K091329 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2009 | 1 |
| 0 (this device) | K142829 | Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo… | Cook Incorporated | 2015 | — |
| +1 | K152913 | GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle | Creganna Medical Aslo Business AS Cregganna Tactx Medical | 2016 | 1 |
| +2 | K171820 | Transjugular Liver Access Sets | Cook Incorporated | 2018 | 2 |
| +1 | K152225 | Edwards eSheath Introducer Set | Edwards Lifesciences | 2015 | — |
| +2 | K162184 | Edwards eSheath Introducer Set | Edward Lifesciences | 2016 | — |
| +2 | K200258 | Edwards eSheath Introducer Set | Edwards Lifesciences | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
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.
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 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? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K091329 | Pinnacle Destination Peripheral Guiding SheathSummary page 5…K142829 Predicate Devices: The subject devices are equivalent to the Pinnacle® Destination® Peripheral Guiding Sheath (K091329, 29 May 2009) and the Cordis Brite Tip® Catheter Sheath Introducer (K984500, 23 December 1998). Comparison to Predicate: It has… | 2009 |
| * | K984500 | Cordis Brite Tip Catheter Sheath Introducer SystemSummary page 5…The subject devices are equivalent to the Pinnacle® Destination® Peripheral Guiding Sheath (K091329, 29 May 2009) and the Cordis Brite Tip® Catheter Sheath Introducer (K984500, 23 December 1998). Comparison to Predicate: It has been demonstrated that Flexor® Tuohy-Borst Side-Arm Introducer Ansel Modifi… | 1998 |
What descends from it? (13)
See all 133 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 26, 2025 | Class II | Z-0993-2026 | Process control | Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly. |
| Nov 12, 2021 | Class II | Z-0387-2022 | Process control | Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa |
| Nov 12, 2021 | Class II | Z-0388-2022 | Process control | Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa |
| Sep 28, 2021 | Class II | Z-0185-2022 | Employee error | Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and… |
| Sep 28, 2021 | Class II | Z-0186-2022 | Employee error | Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and… |
| Nov 24, 2020 | Class I | Z-0592-2021 | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but… |
| Nov 24, 2020 | Class I | Z-0607-2021 | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but… |
| Nov 24, 2020 | Class I | Z-0609-2021 | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but… |
| Nov 24, 2020 | Class I | Z-0594-2021 | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but… |
| Nov 24, 2020 | Class I | Z-0597-2021 | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but… |
| Nov 24, 2020 | Class I | Z-0599-2021 | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but… |
| Nov 24, 2020 | Class I | Z-0601-2021 | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but… |
| Nov 24, 2020 | Class I | Z-0602-2021 | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but… |
| Nov 24, 2020 | Class I | Z-0603-2021 | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but… |
| Nov 24, 2020 | Class I | Z-0604-2021 | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but… |
| Nov 24, 2020 | Class I | Z-0605-2021 | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but… |
| Nov 24, 2020 | Class I | Z-0606-2021 | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but… |
| Nov 24, 2020 | Class I | Z-0610-2021 | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but… |
| Nov 24, 2020 | Class I | Z-0591-2021 | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but… |
| Nov 24, 2020 | Class I | Z-0593-2021 | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but… |
| Nov 24, 2020 | Class I | Z-0596-2021 | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but… |
| Nov 24, 2020 | Class I | Z-0598-2021 | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but… |
| Nov 24, 2020 | Class I | Z-0600-2021 | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but… |
| Nov 24, 2020 | Class I | Z-0595-2021 | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but… |
| Nov 24, 2020 | Class I | Z-0608-2021 | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but… |
| Nov 24, 2020 | Class I | Z-0611-2021 | Process control | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but… |
The 5 latest of 26 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K152913 (Creganna Medical Aslo Business AS Cregganna Tactx Medical, 2016) has gone furthest, with 6 descendants of its own.
- 7 other devices also cite its predicate K091329.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DYB
16in 2025
2007high 30 (2014) · low 9 (2020)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
2007high 156 (2018) · low 37 (2008)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
2007high 45 (2016) · low 1 (2018)2026
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
2007high 4,539 (2025) · low 316 (2007)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) | — |
What is it indicated for?
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature,
excluding coronary and neuro vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142829 · printed Nov 3, 2026
Cite this page
510(k) Report. “K142829: Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K142829
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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