510(k) · Cleared

Recalled · 2004

Introcan Safety IV Catheter

K982805510(k) TraditionalCleared Jan 14, 1999157-day reviewClass II21 CFR 880.5200Recalls 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. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Cleared on Jan 14, 1999 as substantially equivalent to K801941 (Burron Medical Products, Inc., 1980) after a 157-day review. Its family tree reaches back 1 generation to 1980. 70 later devices descend from it. It has been recalled once.

Decided: Jan 14, 1999
Review: 157 days
Class: Class II
Product code: FOZ
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K801941 (1980). 70 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK801941 Burron Microcath Intra. Cath. PlacementtBurron Medical Products, Inc. · 1980
This deviceK982805 Introcan Safety IV CatheterB.Braun Medical, Inc. · 1999
Descendant · cites it directly · 55 of its ownK020785 Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · Recalled
Descendant · cites it directly · 26 of its ownK021094 Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · Recalled
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
Descendant · 2 generations on · 15 of its ownK111236 Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and…B.Braun Melsungen AG · 2011 · Recalled

Showing 5 of 70 descendants. See all descendants

Descendants cleared per year

2002high 7 (2022) · low 0 (2004)2026

Most influential descendants

Showing 5 of 70 · See all

K020785Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · cites it directly55descendants
K021094Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · cites it directly26descendants
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
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 · 2 generations on15descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K801941	Burron Microcath Intra. Cath. Placementt	Burron Medical Products, Inc.	1980	—
0 (this device)	K982805	Introcan Safety IV Catheter	B.Braun Medical, Inc.	1999	—
+1	K020785	Introcan Safety IV Catheter	B.Braun Medical, Inc.	2002	2
+1	K021094	Introcan Safety IV Catheter	B.Braun Medical, Inc.	2002	1
+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
+2	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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	3	0
2003	1	0
2005	1	0
2006	1	0
2007	1	0
2008	2	0
2009	3	0
2010	1	0
2011	3	0
2012	6	0
2013	2	0
2014	5	0
2015	3	0
2016	5	0
2017	4	0
2018	1	0
2019	2	0
2020	5	0
2021	3	0
2022	7	0
2023	1	0
2024	2	0
2025	5	0
2026	3	0

FIG. 1 — Lineage of K982805, 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 FOZ? 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 FOZ device

#1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 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? (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	Applicant	Decided	Recalls
*	K801941	Burron Microcath Intra. Cath. Placementt Summary page 1 …trocan Safety I.V. Catheter Trade Name: Catheter, Intravascular, Short Term Classification name: Hospital Class Il, 80FOZ 21 CFR 880.5200 SUBSTANTIAL EQUIVALENCE' TO: K801941 “ Microcath” ™ Intravenous Burron Medical Inc. Catheter Placement Unit and Catheter Device Description: In accordance with secti…	Burron Medical Products, Inc.	1980	—

Also cleared against K801941: 1 other device →

What descends from it? (70)

See all 70

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

Number	Device	Applicant	Decided	Descendants
K020785	Introcan Safety IV Catheter	B.Braun Medical, Inc.	2002	55
K021094	Introcan Safety IV Catheter	B.Braun Medical, Inc.	2002	26
K121007	Neo Delta Self Safe T, Neo Delta Self Safe T, Neo Delta Self Safe 1, Neo Delta Self Safe 1	Delta Med Srl	2012	0
K063469	Medican Alpha	Eastern Medikit, Ltd.	2006	0
K021488	Surecan Safety Huber Needle Infusion Sets	B.Braun Medical, Inc.	2002	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 19, 2004	Not classified	Z-1092-04	Other	Mislabeled product. The recalling firm received a complaint that a box of Introcan Safety Catheters, (22G x 1 inch) contained mixed 18G catheters with the same lot number.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K020785 (B.Braun Medical, Inc., 2002) has gone furthest, with 55 descendants of its own.
1 other device also cites its predicate K801941.

How does its category compare?

All FOZ devices

FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FOZ

11in 2025

2007high 13 (2012) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FOZ

91in 2025

2007high 242 (2021) · low 28 (2010)2026

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

Recalls per year · FOZ

4in 2023

2007high 115 (2010) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · FOZ

5,110in 2025

2007high 5,110 (2025) · low 370 (2010)2025

MAUDE reports naming product code FOZ, 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	6	159	16	374
2008	9	103	0	422
2009	9	30	23	508
2010	3	28	115	370
2011	6	132	0	786
2012	13	122	0	560
2013	4	104	2	640
2014	9	99	4	815
2015	10	107	0	729
2016	9	63	3 (1)	925
2017	9	51	22	1,966
2018	1	—	4	3,305
2019	8	140	3	4,365
2020	10	191	3	3,797
2021	4	242	1	4,674
2022	8	183	4 (2)	4,133
2023	9	129	4 (2)	4,430
2024	6	190	0	4,772
2025	11	91	0	5,110
2026	7	203	2	—

What is it indicated for?

Passive anti-needle stick device to be placed in a peripheral vein for the infusion of fluids, drugs and/or blood components.

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/K982805 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982805: 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/K982805

Report an extraction error

Are you the manufacturer?

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