510(k) · Cleared

Recalled · Class II · 2025

A6 Luer Access Device

K083723510(k) TraditionalCleared Jun 5, 2009172-day reviewClass II21 CFR 880.5440Recalls 66

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. · FPA Set, Administration, Intravascular

Cleared on Jun 5, 2009 as substantially equivalent to K031923 (B.Braun Medical, Inc., 2003) and 1 other predicate after a 172-day review. Its family tree reaches back 3 generations to 1995. 31 later devices descend from it. It has been recalled 66 times.

Decided: Jun 5, 2009
Review: 172 days
Class: Class II
Product code: FPA
Recalls: 66
Predicates: 2

Its longest line of descent runs back 3 generations to K942988 (1995). 31 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
2 generations backK955585 V2 Injection SiteB.Braun Medical, Inc. · 1996 · Recalled
1 generation backK031923 Ultrasite ValveB.Braun Medical, Inc. · 2003
This deviceK083723 A6 Luer Access DeviceB.Braun Medical, Inc. · 2009
Descendant · cites it directly · 28 of its ownK100434 Clave NeutronIcu Medical, Inc. · 2010 · Recalled
Descendant · 2 generations on · 26 of its ownK132413 MZ1000Care Fusion · 2013
Descendant · 3 generations on · 13 of its ownK140831 Maxzero Extension Set with Needless ConnectorCare Fusion · 2014
Descendant · 3 generations on · 6 of its ownK170336 BD Nexiva Closed IV Catheter System (Single Port) with MaxZero…Becton, Dickinson and Company · 2017
Descendant · 4 generations on · 5 of its ownK183399 BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019 · Recalled

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2010high 6 (2021) · low 0 (2011)2026

Most influential descendants

Showing 5 of 31 · See all

K100434Clave NeutronIcu Medical, Inc. · 2010 · cites it directly28descendants
K132413MZ1000Care Fusion · 2013 · 2 generations on26descendants
K140831Maxzero Extension Set with Needless ConnectorCare Fusion · 2014 · 3 generations on13descendants
K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless ConnectorBecton, Dickinson and Company · 2017 · 3 generations on6descendants
K183399BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019 · 4 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K942988	Filtered Extension Sets	B. Braun of America, Inc.	1995	32
−2	K955585	V2 Injection Site	B.Braun Medical, Inc.	1996	27
−1	K031923	Ultrasite Valve	B.Braun Medical, Inc.	2003	—
0 (this device)	K083723	A6 Luer Access Device	B.Braun Medical, Inc.	2009	—
+1	K100434	Clave Neutron	Icu Medical, Inc.	2010	3
+2	K132413	MZ1000	Care Fusion	2013	—
+3	K140831	Maxzero Extension Set with Needless Connector	Care Fusion	2014	—
+3	K170336	BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless…	Becton, Dickinson and Company	2017	—
+4	K183399	BD Nexiva Closed IV Catheter System	Becton Dickinson Infusion Therapy Systems, Inc.	2019	3

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2013	1	0
2014	3	0
2016	1	0
2017	4	0
2019	2	0
2020	2	0
2021	6	0
2022	2	0
2023	3	0
2024	1	0
2025	3	0
2026	2	0

FIG. 1 — Lineage of K083723, 1995–2026Source: 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 FPA? 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 FPA device

#1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 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? (2)

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
*	K031923	Ultrasite Valve	B.Braun Medical, Inc.	2003	—
*	K955585	V2 Injection Site Summary page 1 …Braun Medical Inc. Ultrasite®Valve [for uise.with power injecotors. (K~03 1923), previously known as B. Braun Medica n.V2Ijction Site (K955585)] DESCRIPTION: B.~ Braun's A6 Luer Access Device is a poitv dipacement valve intended to provide needle-fre…	B.Braun Medical, Inc.	1996	27

What descends from it? (31)

See all 31

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

Number	Device	Applicant	Decided	Descendants
K100434	Clave Neutron	Icu Medical, Inc.	2010	28
K140311	Caresite Luer Access Device	B.Braun Medical, Inc.	2014	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 29, 2025	Class II	Z-0691-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0703-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0685-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0661-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0695-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0660-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0684-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0619-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0676-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0652-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0653-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0615-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0658-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0688-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0612-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0698-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0664-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0690-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0624-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0716-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0692-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0693-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0633-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0699-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0654-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0627-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0622-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0657-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0656-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0625-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0662-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0659-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0689-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0616-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0694-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0663-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0683-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0617-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0687-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0607-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0696-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0628-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0715-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0610-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0706-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0704-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0614-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0609-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0655-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025	Class II	Z-0626-2026	Process control	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

The 5 latest of 50 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
2 of the 3 ancestors have a recall of any class.
Of its descendants, K100434 (Icu Medical, Inc., 2010) has gone furthest, with 28 descendants of its own.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · FPA

11in 2025

2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007high 340 (2023) · low 75 (2007)2026

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

Recalls per year · FPA

98in 2025

2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007high 47,210 (2024) · low 1,499 (2007)2025

MAUDE reports naming product code FPA, 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	16	75	17	1,499
2008	18	89	15	1,941
2009	10	166	166	2,512
2010	23	120	58	2,537
2011	12	87	28	4,407
2012	21	96	16 (4)	4,930
2013	13	90	64	4,651
2014	22	89	24	4,695
2015	17	123	6	6,625
2016	12	195	10	8,470
2017	17	240	13	6,462
2018	4	177	4	6,574
2019	7	161	13	11,227
2020	10	327	107	9,563
2021	13	186	1	10,414
2022	14	213	9 (5)	13,393
2023	14	340	12 (4)	10,916
2024	7	244	13 (1)	47,210
2025	11	225	98 (1)	34,506
2026	5	266	10 (2)	—

What is it indicated for?

The A6 Luer Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The A6 Luer Access Device may be used with power injectors at a maximum pressure of 300 psi and a maximum flow rate of 10 ml/sec.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K083723 · printed Nov 5, 2026

Cite this page

510(k) Report. “K083723: A6 Luer Access Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083723

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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