510(k) · Cleared
ClearedRAILWAY Sheathless Access System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corporation · DYB Introducer, Catheter
Cleared on Apr 18, 2018 as substantially equivalent to K142183 (Terumo Medical Corporation, 2014) after a 97-day review. Its family tree reaches back 6 generations to 1995. 1 of the 12 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 18, 2018
- Review
- 97 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K954234 (1995). 11 ancestors in all, the oldest K810675 (1981). No later device cites it as a predicate yet. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 5 generations backK033681 GlidesheathTerumo Corp. · 2003
- 4 generations backK062858 Modification to GlidesheathTerumo Medical Corp. · 2006
- 3 generations backK082644 GlidesheathTerumo Medical Corp. · 2008
- 2 generations backK122980 Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model…Terumo Medical Corporation · 2012
- 1 generation backK142183 Glidesheath SlenderTerumo Medical Corporation · 2014 · Recalled
- This deviceK180081 RAILWAY Sheathless Access SystemCordis Corporation · 2018
Class I recalls in this family
- K810675 Arrow Radial Artery Catheterization Set5 generations back · 1981
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −5 | K033681 | Glidesheath | Terumo Corp. | 2003 | — |
| −4 | K062858 | Modification to Glidesheath | Terumo Medical Corp. | 2006 | — |
| −3 | K082644 | Glidesheath | Terumo Medical Corp. | 2008 | — |
| −2 | K122980 | Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM*… | Terumo Medical Corporation | 2012 | — |
| −1 | K142183 | Glidesheath Slender | Terumo Medical Corporation | 2014 | 17 |
| 0 (this device) | K180081 | RAILWAY Sheathless Access System | Cordis Corporation | 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 |
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 |
|---|---|---|---|
| * | K142183 | Glidesheath SlenderSummary page 4…er Classification Name: Introducer, Catheter (21 CFR 870.1340), Class II Product Code: DYB III. PREDICATE DEVICE Terumo Glidesheath Slender® cleared on 11/21/2014 under K142183 Reference device Terumo Glidesheath Slender® cleared on 12/11/2012 under K122980 Asahi Sheathless Eaucath Coronary Guide Cathete… | 2014 |
| † | K122980 | Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM* ES6F16HQ… | 2012 |
| † | K132556 | Sheathless Eaucath Coronary Guide Catheter | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 5 generations back · ◆ in the 1981 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 3 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
- 4 other devices also cite its predicate K142183.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 RAILWAY Sheathless Access System is indicated for use in radial arterial procedures requiring percutaneous introduction of intravascular devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180081: RAILWAY Sheathless Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180081
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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