510(k) · Cleared

Recalled · Class II · 2013

Introcan Safety IV Catheter

K021094510(k) TraditionalCleared Jul 3, 200290-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

B.Braun Medical, Inc. · DYB Introducer, Catheter

Cleared on Jul 3, 2002 as substantially equivalent to K982805 (B.Braun Medical, Inc., 1999) and 3 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1980. 26 later devices descend from it. It has been recalled once.

Decided: Jul 3, 2002
Review: 90 days
Class: Class II
Product code: DYB
Recalls: 1
Predicates: 4

Its longest line of descent runs back 2 generations to K801941 (1980). 5 ancestors in all. 26 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK801941 Burron Microcath Intra. Cath. PlacementtBurron Medical Products, Inc. · 1980
1 generation backK982805 Introcan Safety IV CatheterB.Braun Medical, Inc. · 1999 · Recalled
This deviceK021094 Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002
Descendant · cites it directly · 15 of its ownK111236 Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and…B.Braun Melsungen AG · 2011 · Recalled
Descendant · 2 generations on · 9 of its ownK163358 Introcan Safety 3 Closed IV CatheterB.Braun Melsungen AG · 2017
Descendant · 2 generations on · 8 of its ownK182870 Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc. · 2019 · Recalled
Descendant · cites it directly · 7 of its ownK030135 Safety Introducer NeedleB.Braun Medical, Inc. · 2003
Descendant · 3 generations on · 6 of its ownK192676 Introcan Safety 2 IV Catheter 18-24 gaugeB.Braun Medical, Inc. · 2020

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2003high 4 (2020) · low 0 (2004)2026

Most influential descendants

Showing 5 of 26 · See all

K111236Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4 (32MM) /…B.Braun Melsungen AG · 2011 · cites it directly15descendants
K163358Introcan Safety 3 Closed IV CatheterB.Braun Melsungen AG · 2017 · 2 generations on9descendants
K182870Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc. · 2019 · 2 generations on8descendants
K030135Safety Introducer NeedleB.Braun Medical, Inc. · 2003 · cites it directly7descendants
K192676Introcan Safety 2 IV Catheter 18-24 gaugeB.Braun Medical, Inc. · 2020 · 3 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K801941	Burron Microcath Intra. Cath. Placementt	Burron Medical Products, Inc.	1980	—
−1	K982805	Introcan Safety IV Catheter	B.Braun Medical, Inc.	1999	1
0 (this device)	K021094	Introcan Safety IV Catheter	B.Braun Medical, Inc.	2002	—
+1	K111236	Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4…	B.Braun Melsungen AG	2011	1
+2	K163358	Introcan Safety 3 Closed IV Catheter	B.Braun Melsungen AG	2017	—
+2	K182870	Introcan Safety 3 Closed IV Catheter	B.Braun Medical, Inc.	2019	1
+1	K030135	Safety Introducer Needle	B.Braun Medical, Inc.	2003	—
+3	K192676	Introcan Safety 2 IV Catheter 18-24 gauge	B.Braun Medical, Inc.	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	2	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0
2007	1	0
2011	1	0
2012	1	0
2014	1	0
2015	1	0
2016	1	0
2017	2	0
2018	1	0
2019	1	0
2020	4	0
2021	1	0
2022	3	0
2023	1	0
2024	1	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K021094, 1980–2026Source: 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? (4)

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
*	K982805	Introcan Safety IV Catheter Summary page 1 …r Catheter and CLASSIFICATION: 21 CFR 5 870.1340: Catheter Introducer PREDICATE DEVICE: B. Braun Medical Inc. Introcan Safety IV Catheter (K982805) B. Braun Medical Inc. Introducer Catheter (Kit component of…	B.Braun Medical, Inc.	1999	1
*	K810460	Burron Percutaneous Inducer Set Summary page 1 …Introcan Safety IV Catheter (K982805) B. Braun Medical Inc. Introducer Catheter (Kit component of K8 10460 / K8 10461) Becton Dickinson Infusion Therapy Systems Inc., BD IntrosyteTM…	Burron Medical Products, Inc.	1981	—
*	K810461	Burron Central Vein Catherization Kit Summary page 1 …afety IV Catheter (K982805) B. Braun Medical Inc. Introducer Catheter (Kit component of K8 10460 / K8 10461) Becton Dickinson Infusion Therapy Systems Inc., BD IntrosyteTM…	Burron Medical Products, Inc.	1981	—
*	K013304	BD Introsyte Precision Introducer, BD Introsyte Autogaurd Shielded Introducer Summary page 1 …1) Becton Dickinson Infusion Therapy Systems Inc., BD IntrosyteTM AutoguardT" Shielded Introducer (K013304) DESCRIPTION: The Introcan Safety IV Catheter consists of an over-the-needle…	Becton Dickinson Infusion Therapy Systems, Inc.	2002	—

Also cleared against K982805: 4 other devices →

What descends from it? (26)

See all 26

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

Number	Device	Applicant	Decided	Descendants
K111236	Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4 (32MM) /…	B.Braun Melsungen AG	2011	15
K030135	Safety Introducer Needle	B.Braun Medical, Inc.	2003	7
K201075	BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter…	Becton, Dickinson and Company	2020	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 27, 2013	Class II	Z-0559-2014	Labeling False and Misleading	One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 18.4 years on median.
1 of the 5 ancestors has a recall of any class.
Of its descendants, K111236 (B.Braun Melsungen AG, 2011) has gone furthest, with 15 descendants of its own.
4 other devices also cite its predicate K982805.

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?

The Introcan® Safety™ IV Catheter is a passive anti-needle stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central Catheters, and midline catheters into the vascular system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021094 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021094: Introcan Safety IV Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021094

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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