510(k) · Cleared
ClearedModification to Glidesheath
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 Oct 20, 2006 as substantially equivalent to K033681 (Terumo Corp., 2003) after a 25-day review. Its family tree reaches back 2 generations to 1995. 42 later devices descend from it.
- Decided
- Oct 20, 2006
- Review
- 25 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954234 (1995). 42 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 1 generation backK033681 GlidesheathTerumo Corp. · 2003
- This deviceK062858 Modification to GlidesheathTerumo Medical Corp. · 2006
- Descendant · cites it directly · 41 of its ownK082644 GlidesheathTerumo Medical Corp. · 2008
- Descendant · 2 generations on · 17 of its ownK102008 GlidesheathTerumo Medical Corp. · 2010 · Recalled
- Descendant · 2 generations on · 12 of its ownK122980 Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model…Terumo Medical Corporation · 2012
- Descendant · 3 generations on · 8 of its ownK142183 Glidesheath SlenderTerumo Medical Corporation · 2014 · Recalled
- Descendant · 3 generations on · 7 of its ownK111606 Pinnacle Precision Access SystemTerumo Medical Corp. · 2011 · Recalled
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K082644GlidesheathTerumo Medical Corp. · 2008 · cites it directly41descendants
- K102008GlidesheathTerumo Medical Corp. · 2010 · 2 generations on17descendants
- K122980Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM* ES6F16HQ…Terumo Medical Corporation · 2012 · 2 generations on12descendants
- K142183Glidesheath SlenderTerumo Medical Corporation · 2014 · 3 generations on8descendants
- K111606Pinnacle Precision Access SystemTerumo Medical Corp. · 2011 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −1 | K033681 | Glidesheath | Terumo Corp. | 2003 | — |
| 0 (this device) | K062858 | Modification to Glidesheath | Terumo Medical Corp. | 2006 | — |
| +1 | K082644 | Glidesheath | Terumo Medical Corp. | 2008 | — |
| +2 | K102008 | Glidesheath | Terumo Medical Corp. | 2010 | 1 |
| +2 | K122980 | Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM*… | Terumo Medical Corporation | 2012 | — |
| +3 | K142183 | Glidesheath Slender | Terumo Medical Corporation | 2014 | 17 |
| +3 | K111606 | Pinnacle Precision Access System | Terumo Medical Corp. | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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.
Planning a device in DYB? 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? (1)
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 |
|---|---|---|---|
| * | K033681 | GlidesheathSummary page 1…h while it remains in place within the vein or artery after removal of a catheter. Note: This is the same intended use as the predicate device, Glidesheath K033681. C. Device Description The Glidesheath is comprised of an introducer sheath and a dilator. The Glidesheath is use… | 2003 |
What descends from it? (42)
See all 421 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082644 | Glidesheath | 2008 | 41 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 8.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K082644 (Terumo Medical Corp., 2008) has gone furthest, with 41 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) | — |
What is it indicated for?
The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or 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 after removal of a catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062858 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062858: Modification to Glidesheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062858
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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