510(k) · Cleared

Recalled · Class II · 2019

Daig Fast Cath (TM) Introducer, Modification

K914090510(k) TraditionalCleared Oct 28, 199147-day reviewClass II21 CFR 870.1340Recalls 1

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

Daig Corp. · DYB Introducer, Catheter

Cleared on Oct 28, 1991 after a 47-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it. It has been recalled once.

Decided: Oct 28, 1991
Review: 47 days
Class: Class II
Product code: DYB
Recalls: 1
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK914090 Daig Fast Cath (TM) Introducer, ModificationDaig Corp. · 1991
Descendant · cites it directly · 0 of its ownK093130 Engage TR IntroducerSt Jude Medical · 2009 · Recalled
Descendant · cites it directly · 0 of its ownK092575 Engage/Engage TRSt Jude Medical · 2009 · Recalled

Most influential descendants

Showing 2 of 2 · See all

K093130Engage TR IntroducerSt Jude Medical · 2009 · cites it directly0descendants
K092575Engage/Engage TRSt Jude Medical · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K914090	Daig Fast Cath (TM) Introducer, Modification	Daig Corp.	1991	—
+1	K093130	Engage TR Introducer	St Jude Medical	2009	5
+1	K092575	Engage/Engage TR	St Jude Medical	2009	5

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	2	0

FIG. 1 — Lineage of K914090, 1991–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K093130	Engage TR Introducer	St Jude Medical	2009	0
K092575	Engage/Engage TR	St Jude Medical	2009	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 9, 2019	Class II	Z-0789-2020	Packaging	Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K093130 (St Jude Medical, 2009) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DYB

16in 2025

2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007high 156 (2018) · low 37 (2008)2026

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

Recalls per year · DYB

3in 2025

2007high 45 (2016) · low 1 (2018)2026

Class I (48 since 2007) Class II/III not classified

Adverse event reports per year · DYB

4,539in 2025

2007high 4,539 (2025) · low 316 (2007)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)	—

https://510kreport.com/device/K914090 · printed Nov 6, 2026

Cite this page

510(k) Report. “K914090: Daig Fast Cath (TM) Introducer, Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914090

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026