510(k) · Cleared

Cleared

BD Introsyte Precision Introducer; BD Introsyte-N Precision Introducer; BD Introsyte Autoguard Shielded Introducer; BD I

K020834510(k) TraditionalCleared Jun 12, 200290-day reviewClass II21 CFR 870.1340

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

Becton Dickinson Infusion Therapy Systems, Inc. · DYB Introducer, Catheter

Cleared on Jun 12, 2002 after a 90-day review. The FDA summary names its predicate without a number. 37 later devices descend from it.

Decided: Jun 12, 2002
Review: 90 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 0

37 later devices descend from it, 5 citing it directly.

This deviceK020834 BD Introsyte Precision Introducer; BD Introsyte-N Precision…Becton Dickinson Infusion Therapy Systems, Inc. · 2002
Descendant · cites it directly · 32 of its ownK090372 The Wand Microaccess Safety IntroducerAccess Scientific, Inc. · 2009
Descendant · 2 generations on · 31 of its ownK093022 The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc. · 2010
Descendant · cites it directly · 27 of its ownK081697 The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005…Access Scientific, Inc. · 2008
Descendant · 2 generations on · 25 of its ownK101422 The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011
Descendant · 3 generations on · 19 of its ownK121073 Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · Recalled

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

2008high 4 (2012) · low 0 (2023)2026

Most influential descendants

Showing 5 of 37 · See all

K090372The Wand Microaccess Safety IntroducerAccess Scientific, Inc. · 2009 · cites it directly32descendants
K093022The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc. · 2010 · 2 generations on31descendants
K081697The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006Access Scientific, Inc. · 2008 · cites it directly27descendants
K101422The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011 · 2 generations on25descendants
K121073Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · 3 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K020834	BD Introsyte Precision Introducer; BD Introsyte-N Precision Introducer; BD…	Becton Dickinson Infusion Therapy Systems, Inc.	2002	—
+1	K090372	The Wand Microaccess Safety Introducer	Access Scientific, Inc.	2009	—
+2	K093022	The Picc Wand Peelable Safety Introducer	Access Scientific, Inc.	2010	—
+1	K081697	The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006	Access Scientific, Inc.	2008	—
+2	K101422	The Power Wand Safety Introducer with an Extended Dwell Catheter	Access Scientific, Inc.	2011	—
+3	K121073	Powerglide Midline Catheter	C.R. Bard, Inc.	2012	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0
2010	3	0
2011	3	0
2012	4	0
2013	3	0
2014	4	0
2015	2	0
2016	4	0
2017	1	0
2018	1	0
2019	1	0
2020	1	0
2021	2	0
2022	2	0
2024	1	0
2025	3	0

FIG. 1 — Lineage of K020834, 2002–2025Source: 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 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? (5)

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	Recalls
*	—	BD Introsyte™ Precision Introducer Named without a submission number	—
*	—	BD Introsyte-NT™ Precision Introducer Named without a submission number	—
*	—	BD Introsyte™ Autoguard™ Shielded Introducer Named without a submission number	—
*	—	BD Introsyte-NT™ Autoguard™ Shielded Introducer Named without a submission number	—
*	—	BD Splittable Needle Introducer Named without a submission number	—

What descends from it? (37)

See all 37

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

Number	Device	Applicant	Decided	Descendants
K090372	The Wand Microaccess Safety Introducer	Access Scientific, Inc.	2009	32
K081697	The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006	Access Scientific, Inc.	2008	27
K141969	Firststic N Introducer	Argon Medical Devices, Inc.	2014	0
K113196	Vascular Sono	PAJUNK GmbH Medizintechnologie	2012	0
K092097	A.B. Korkor Medical Skinnysafe Introducer Sheath	A.B. Korkor Medical, Inc.	2010	0

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?

Of its descendants, K090372 (Access Scientific, Inc., 2009) has gone furthest, with 32 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)	—

What is it indicated for?

As provided in 21 CFR 870.1340, a catheter introducer is a sheath used to

facilitate placing a catheter through the skin into a vein or artery.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K020834 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020834: BD Introsyte Precision Introducer; BD Introsyte-N Precision Introducer; BD Introsyte Autoguard Shielded Introducer; BD I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020834

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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