510(k) · Cleared
ClearedGlidesheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corp. · DYB Introducer, Catheter
Cleared on Sep 18, 2008 as substantially equivalent to K062858 (Terumo Medical Corp., 2006) and 1 other predicate after a 7-day review. Its family tree reaches back 3 generations to 1995. 1 of the 50 devices in its family, counting itself, has a Class I recall. 41 later devices descend from it.
- Decided
- Sep 18, 2008
- Review
- 7 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K954234 (1995). 8 ancestors in all, the oldest K810675 (1981). 41 later devices descend from it, 9 citing it directly. 1 of the 50 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 2 generations backK033681 GlidesheathTerumo Corp. · 2003
- 1 generation backK062858 Modification to GlidesheathTerumo Medical Corp. · 2006
- This deviceK082644 GlidesheathTerumo Medical Corp. · 2008
- Descendant · cites it directly · 17 of its ownK102008 GlidesheathTerumo Medical Corp. · 2010 · Recalled
- Descendant · cites it directly · 12 of its ownK122980 Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model…Terumo Medical Corporation · 2012
- Descendant · 2 generations on · 8 of its ownK142183 Glidesheath SlenderTerumo Medical Corporation · 2014 · Recalled
- Descendant · 2 generations on · 7 of its ownK111606 Pinnacle Precision Access SystemTerumo Medical Corp. · 2011 · Recalled
- Descendant · 2 generations on · 6 of its ownK140543 Preludeease Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2014 · Recalled
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K810675 Arrow Radial Artery Catheterization Set2 generations back · 1981
Most influential descendants
Showing 5 of 41 · See all- K102008GlidesheathTerumo Medical Corp. · 2010 · cites it directly17descendants
- K122980Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM* ES6F16HQ…Terumo Medical Corporation · 2012 · cites it directly12descendants
- K142183Glidesheath SlenderTerumo Medical Corporation · 2014 · 2 generations on8descendants
- K111606Pinnacle Precision Access SystemTerumo Medical Corp. · 2011 · 2 generations on7descendants
- K140543Preludeease Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2014 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −2 | K033681 | Glidesheath | Terumo Corp. | 2003 | — |
| −1 | K062858 | Modification to Glidesheath | Terumo Medical Corp. | 2006 | — |
| 0 (this device) | K082644 | Glidesheath | Terumo Medical Corp. | 2008 | — |
| +1 | K102008 | Glidesheath | Terumo Medical Corp. | 2010 | 1 |
| +1 | K122980 | Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM*… | Terumo Medical Corporation | 2012 | — |
| +2 | K142183 | Glidesheath Slender | Terumo Medical Corporation | 2014 | 17 |
| +2 | K111606 | Pinnacle Precision Access System | Terumo Medical Corp. | 2011 | 1 |
| +2 | K140543 | Preludeease Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | 2014 | 1 |
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 |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2014 | 7 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 8 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K062858 | Modification to GlidesheathSummary page 2…ly or by a manual process. E. Design /Materials Differences in materials between the modified device and the predicate device the Glidesheath cleared under K062858 and the Cordis AvantiT M cleared under K962746 raise no new issues of safety and effectiveness. F. Specifications… | 2006 |
| * | K962746 | Cordis Avanti Trans-Radial Catheter Sheath Introducer KitSummary page 2…ls Differences in materials between the modified device and the predicate device the Glidesheath cleared under K062858 and the Cordis AvantiT M cleared under K962746 raise no new issues of safety and effectiveness. F. Specifications Sheath Sizes: 4, 5 & 6 French… | 1996 |
What descends from it? (41)
See all 419 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102008 | Glidesheath | 2010 | 17 |
| K122980 | Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM* ES6F16HQ… | 2012 | 12 |
| K110051 | Radialsource Transradial Access Introducer Kit | 2012 | 3 |
| K091137 | Ultimum/Engage/Engage TR | 2009 | 2 |
| K152173 | Glidesheath | 2015 | 1 |
| K162097 | InTRAkit | 2016 | 0 |
| K142051 | Prelude Plastic Jacketed Guide Wire | 2014 | 0 |
| K132789 | Flip Introducer Access Kit | 2014 | 0 |
| K112554 | Transradial Artery Access Devices | 2011 | 0 |
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.
- 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 13 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K102008 (Terumo Medical Corp., 2010) has gone furthest, with 17 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. 2008, 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 Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.
The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery including but not limited to the radial artery.
The Radifocus Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery, including but not limited to the radial artery, after removal of a catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082644 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082644: Glidesheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082644
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