510(k) · Cleared
Recalled · Class II · 2017Glidesheath Slender
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corporation · DYB Introducer, Catheter
Cleared on Nov 21, 2014 as substantially equivalent to K122980 (Terumo Medical Corporation, 2012) after a 105-day review. Its family tree reaches back 5 generations to 1995. 1 of the 19 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it. It has been recalled 17 times.
- Decided
- Nov 21, 2014
- Review
- 105 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 17
- Predicates
- 1
Its longest line of descent runs back 5 generations to K954234 (1995). 10 ancestors in all, the oldest K810675 (1981). 8 later devices descend from it, 5 citing it directly. 1 of the 19 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 4 generations backK033681 GlidesheathTerumo Corp. · 2003
- 3 generations backK062858 Modification to GlidesheathTerumo Medical Corp. · 2006
- 2 generations backK082644 GlidesheathTerumo Medical Corp. · 2008
- 1 generation backK122980 Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model…Terumo Medical Corporation · 2012
- This deviceK142183 Glidesheath SlenderTerumo Medical Corporation · 2014
- Descendant · cites it directly · 2 of its ownK181237 Glidesheath Slender Tibial Pedal KitTerumo Medical Corporation · 2018
- Descendant · cites it directly · 1 of its ownK173831 Glidesheath SlenderTerumo Medical Corporation · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK230704 RAIN Sheath™ Tibial Pedal IntroducerCordis US Corp · 2023
- Descendant · 2 generations on · 0 of its ownK220604 EXTesia Introducer Sheath SetCuratia Medical Co. · 2022
- Descendant · 2 generations on · 0 of its ownK193160 Glidesheath Slender Tibial Pedal KitTerumo Medical Coporation · 2019
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K810675 Arrow Radial Artery Catheterization Set4 generations back · 1981
Most influential descendants
Showing 5 of 8 · See all- K181237Glidesheath Slender Tibial Pedal KitTerumo Medical Corporation · 2018 · cites it directly2descendants
- K173831Glidesheath SlenderTerumo Medical Corporation · 2018 · cites it directly1descendant
- K230704RAIN Sheath™ Tibial Pedal IntroducerCordis US Corp · 2023 · 2 generations on0descendants
- K220604EXTesia Introducer Sheath SetCuratia Medical Co. · 2022 · 2 generations on0descendants
- K193160Glidesheath Slender Tibial Pedal KitTerumo Medical Coporation · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −4 | K033681 | Glidesheath | Terumo Corp. | 2003 | — |
| −3 | K062858 | Modification to Glidesheath | Terumo Medical Corp. | 2006 | — |
| −2 | K082644 | Glidesheath | Terumo Medical Corp. | 2008 | — |
| −1 | K122980 | Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM*… | Terumo Medical Corporation | 2012 | — |
| 0 (this device) | K142183 | Glidesheath Slender | Terumo Medical Corporation | 2014 | — |
| +1 | K181237 | Glidesheath Slender Tibial Pedal Kit | Terumo Medical Corporation | 2018 | — |
| +1 | K173831 | Glidesheath Slender | Terumo Medical Corporation | 2018 | 1 |
| +2 | K230704 | RAIN Sheath™ Tibial Pedal Introducer | Cordis US Corp | 2023 | — |
| +2 | K220604 | EXTesia Introducer Sheath Set | Curatia Medical Co. | 2022 | — |
| +2 | K193160 | Glidesheath Slender Tibial Pedal Kit | Terumo Medical Coporation | 2019 | — |
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 |
|---|---|---|
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K122980 | Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM* ES6F16HQ…Summary page 5…h substantial equivalence is claimed is the current Glidesheath Slender (6Fr) which is manufactured by Ashitaka Factory of Terumo Corporation and was cleared under K122980. D. Reason for 510(k) Submission This premarket notification (Special 510(k)) is being submitted to extend the current Gl… | 2012 |
| † | K891087 | Terumo Surflo (R) I.V. Catheter | 1989 |
| † | K082644 | Glidesheath | 2008 |
| † | K954234 | Radifocus Introducer II Kit | 1995 |
What descends from it? (8)
5 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 |
|---|---|---|---|---|
| Jun 7, 2017 | Class II | Z-0219-2018 | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier… |
| Jun 7, 2017 | Class II | Z-0227-2018 | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier… |
| Jun 7, 2017 | Class II | Z-0214-2018 | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier… |
| Jun 7, 2017 | Class II | Z-0216-2018 | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier… |
| Jun 7, 2017 | Class II | Z-0217-2018 | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier… |
| Jun 7, 2017 | Class II | Z-0221-2018 | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier… |
| Jun 7, 2017 | Class II | Z-0226-2018 | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier… |
| Jun 7, 2017 | Class II | Z-0228-2018 | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier… |
| Jun 7, 2017 | Class II | Z-0229-2018 | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier… |
| Jun 7, 2017 | Class II | Z-0218-2018 | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier… |
| Jun 7, 2017 | Class II | Z-0220-2018 | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier… |
| Jun 7, 2017 | Class II | Z-0222-2018 | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier… |
| Jun 7, 2017 | Class II | Z-0224-2018 | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier… |
| Jun 7, 2017 | Class II | Z-0225-2018 | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier… |
| Jun 7, 2017 | Class II | Z-0215-2018 | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier… |
| Jun 7, 2017 | Class II | Z-0223-2018 | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier… |
| Jun 7, 2017 | Class II | Z-0230-2018 | Nonconforming Material/Component | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier… |
The 5 latest of 17 recalls; the web page lists all.
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 · 4 generations back · ◆ in the 1981 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K181237 (Terumo Medical Corporation, 2018) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K122980.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Slender is used to facilitate placing a catheter through the skin into the radial artery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142183: Glidesheath Slender.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142183
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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