510(k) · Cleared
ClearedGlidesheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Corp. · DYB Introducer, Catheter
Cleared on Dec 11, 2003 as substantially equivalent to K954234 (Terumo Medical Corp., 1995) after a 17-day review. Its family tree reaches back 1 generation to 1995. 43 later devices descend from it.
- Decided
- Dec 11, 2003
- Review
- 17 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954234 (1995). 43 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- This deviceK033681 GlidesheathTerumo Corp. · 2003
- Descendant · cites it directly · 42 of its ownK062858 Modification to GlidesheathTerumo Medical Corp. · 2006
- Descendant · 2 generations on · 41 of its ownK082644 GlidesheathTerumo Medical Corp. · 2008
- Descendant · 3 generations on · 17 of its ownK102008 GlidesheathTerumo Medical Corp. · 2010 · Recalled
- Descendant · 3 generations on · 12 of its ownK122980 Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model…Terumo Medical Corporation · 2012
- Descendant · 4 generations on · 8 of its ownK142183 Glidesheath SlenderTerumo Medical Corporation · 2014 · Recalled
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K062858Modification to GlidesheathTerumo Medical Corp. · 2006 · cites it directly42descendants
- K082644GlidesheathTerumo Medical Corp. · 2008 · 2 generations on41descendants
- K102008GlidesheathTerumo Medical Corp. · 2010 · 3 generations on17descendants
- K122980Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM* ES6F16HQ…Terumo Medical Corporation · 2012 · 3 generations on12descendants
- K142183Glidesheath SlenderTerumo Medical Corporation · 2014 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| 0 (this device) | K033681 | Glidesheath | Terumo Corp. | 2003 | — |
| +1 | K062858 | Modification to Glidesheath | Terumo Medical Corp. | 2006 | — |
| +2 | K082644 | Glidesheath | Terumo Medical Corp. | 2008 | — |
| +3 | K102008 | Glidesheath | Terumo Medical Corp. | 2010 | 1 |
| +3 | K122980 | Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM*… | Terumo Medical Corporation | 2012 | — |
| +4 | K142183 | Glidesheath Slender | Terumo Medical Corporation | 2014 | 17 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K954234 | Radifocus Introducer II KitSummary page 1…oval of a catheter. ® Note: This is the same intended use as the RADIFOCUS Introducer II Kit, K954234. C. Device Description The Glidesheath is comprised of an introducer sheath and a dilator. The Glidesheat… | 1995 |
What descends from it? (43)
See all 431 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062858 | Modification to Glidesheath | 2006 | 42 |
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?
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/K033681 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033681: Glidesheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033681
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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