510(k) · Cleared

Cleared

Railwire

K954552510(k) TraditionalCleared Apr 29, 1996210-day reviewClass II21 CFR 870.1330

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boston Scientific /International Technologies · DQX Wire, Guide, Catheter

Cleared on Apr 29, 1996 as substantially equivalent to K895903 (Intensive Technology, Inc., 1990) and 1 other predicate after a 210-day review. Its family tree reaches back 1 generation to 1988.

Decided: Apr 29, 1996
Review: 210 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K882804 (1988). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK882804 0.014 Peripheral Guide WireIntensive Technology, Inc. · 1988
This deviceK954552 RailwireBoston Scientific /International Technologies · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K882804	0.014 Peripheral Guide Wire	Intensive Technology, Inc.	1988	—
0 (this device)	K954552	Railwire	Boston Scientific /International Technologies	1996	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0

FIG. 1 — Lineage of K954552, 1988–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DQX? 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 DQX device

#1 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (3)

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	Applicant	Decided	Recalls
*	K895903	Ivt 0.014 Guide Wire Summary page 1 …ires classified under 21 CFR 870.1330 PREDICATED DEVICES: IVT is claiming substantial equivalence to the following predicate medical devices: 1. IVT 0.014" Guidewire (K895903) 2. IVT 0.014" Peripheral Guidewire (K882804) 3. Cook Family of Guidewires DEVICE DESCRIPTION: The IVT 0.014% Railwire™ is con…	Intensive Technology, Inc.	1990	—
*	K882804	0.014 Peripheral Guide Wire Summary page 1 …ATED DEVICES: IVT is claiming substantial equivalence to the following predicate medical devices: 1. IVT 0.014" Guidewire (K895903) 2. IVT 0.014" Peripheral Guidewire (K882804) 3. Cook Family of Guidewires DEVICE DESCRIPTION: The IVT 0.014% Railwire™ is constructed from a stainless steel core wire tha…	Intensive Technology, Inc.	1988	—
*	—	Cook Family of Guidewires Named without a submission number			—

Also cleared against K895903: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

None of the 2 ancestors has a recall.
1 other device also cites its predicate K895903.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQX

10in 2025

2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007high 212 (2022) · low 43 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQX

3in 2024

2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007high 2,210 (2024) · low 687 (2009)2025

MAUDE reports naming product code DQX, 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	14	85	12	760
2008	19	87	7	715
2009	18	87	49	687
2010	21	63	34	987
2011	18	43	3	1,311
2012	20	62	5	1,337
2013	18	119	7 (4)	1,474
2014	18	103	0	1,323
2015	15	112	1	1,323
2016	14	179	2 (2)	1,466
2017	19	85	17	1,524
2018	19	114	9	1,737
2019	13	173	2	1,679
2020	14	106	1 (1)	1,536
2021	6	161	0	1,713
2022	15	212	0	1,647
2023	10	136	0	2,068
2024	11	134	3	2,210
2025	10	177	0	2,178
2026	12	145	4 (1)	—

What is it indicated for?

The IVT 0.014" Railwire™ is intended to facilitate the navigation and placement of angioplasty and interventional devices through tortuous peripheral and coronary vessels.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K954552 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954552: Railwire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954552

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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