510(k) · Cleared
Recalled · Class II · 2013Radialsource Transradial Access Introducer Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Great Batch Medical · DYB Introducer, Catheter
Cleared on Feb 2, 2012 as substantially equivalent to K082644 (Terumo Medical Corp., 2008) and 1 other predicate after a 391-day review. Its family tree reaches back 4 generations to 1995. 1 of the 13 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled once.
- Decided
- Feb 2, 2012
- Review
- 391 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K954234 (1995). 9 ancestors in all, the oldest K810675 (1981). 3 later devices descend from it, 1 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 3 generations backK033681 GlidesheathTerumo Corp. · 2003
- 2 generations backK062858 Modification to GlidesheathTerumo Medical Corp. · 2006
- 1 generation backK082644 GlidesheathTerumo Medical Corp. · 2008
- This deviceK110051 Radialsource Transradial Access Introducer KitGreat Batch Medical · 2012
- Descendant · cites it directly · 2 of its ownK132592 Flexor Radial Hydrophilic Introducer Access SetCook, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK152044 Flexor Radial Hydrophilic Introducer Access SetCook Incorporated · 2015
- Descendant · 3 generations on · 0 of its ownK171609 Check-Flo Performer Introducer Micropuncture Radial Artery Access SetCook Incorporated · 2018
Class I recalls in this family
- K810675 Arrow Radial Artery Catheterization Set2 generations back · 1981
Most influential descendants
Showing 3 of 3 · See all- K132592Flexor Radial Hydrophilic Introducer Access SetCook, Inc. · 2014 · cites it directly2descendants
- K152044Flexor Radial Hydrophilic Introducer Access SetCook Incorporated · 2015 · 2 generations on1descendant
- K171609Check-Flo Performer Introducer Micropuncture Radial Artery Access SetCook Incorporated · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −3 | K033681 | Glidesheath | Terumo Corp. | 2003 | — |
| −2 | K062858 | Modification to Glidesheath | Terumo Medical Corp. | 2006 | — |
| −1 | K082644 | Glidesheath | Terumo Medical Corp. | 2008 | — |
| 0 (this device) | K110051 | Radialsource Transradial Access Introducer Kit | Great Batch Medical | 2012 | — |
| +1 | K132592 | Flexor Radial Hydrophilic Introducer Access Set | Cook, Inc. | 2014 | 7 |
| +2 | K152044 | Flexor Radial Hydrophilic Introducer Access Set | Cook Incorporated | 2015 | — |
| +3 | K171609 | Check-Flo Performer Introducer Micropuncture Radial Artery Access Set | Cook Incorporated | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 1 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 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 |
|---|---|---|---|
| * | K082644 | GlidesheathSummary page 1…on: Class 11 21 CFR 870.1340 Classification Panel: Cardiovascular Predicates: Terumo Glidesheath (K082644) Cordis Avanti Trans-Radial Kit (K962746) 3.0 Device Description The RadialSource… | 2008 |
| * | K962746 | Cordis Avanti Trans-Radial Catheter Sheath Introducer KitSummary page 1…Cardiovascular Predicates: Terumo Glidesheath (K082644) Cordis Avanti Trans-Radial Kit (K962746) 3.0 Device Description The RadialSourceTM Transradial Access (TRA) Kit consists of a catheter sheath introducer (CSI), a v… | 1996 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132592 | Flexor Radial Hydrophilic Introducer Access Set | 2014 | 2 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 31, 2013 | Class II | Z-1608-2013 | Process control | Cordis Corporation, Inc and Greatbatch Medical are recalling one lot of the cordis RADIALSOURCE Spring Wire Transradial Access Kit product. Some units were manufactured with an undersized vessel dilator tip, too small to slide over the… |
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.
- K810675Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · 2 generations back · ◆ in the 1981 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 2 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K132592 (Cook, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 8 other devices also cite its predicate K082644.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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) | — |
What is it indicated for?
The RadialSource Catheter Sheath Introducer is indicated for use in arterial or venous procedures requiring percutaneous introduction of intravascular devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110051: Radialsource Transradial Access Introducer Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110051
Report an extraction error
Are you the manufacturer?
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