510(k) · Cleared

Recalled · Class II · 2015

BD Saf-T PRN Luer Activated Valve, Model 385100

K013621510(k) TraditionalCleared Apr 16, 2002162-day reviewClass II21 CFR 880.5440Recalls 11

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. · FPA Set, Administration, Intravascular

Cleared on Apr 16, 2002 as substantially equivalent to K970855 (Icu Medical, Inc., 1997) after a 162-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it. It has been recalled 11 times.

Decided: Apr 16, 2002
Review: 162 days
Class: Class II
Product code: FPA
Recalls: 11
Predicates: 1

Its longest line of descent runs back 1 generation to K970855 (1997). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK970855 Clave ConnectorIcu Medical, Inc. · 1997 · Recalled
This deviceK013621 BD Saf-T PRN Luer Activated Valve, Model 385100Becton Dickinson Infusion Therapy Systems, Inc. · 2002
Descendant · cites it directly · 1 of its ownK142527 Extension Set with BD Q-Syte Luer Access Split SeptumAcacia, Inc. · 2014
Descendant · 2 generations on · 0 of its ownK202672 Precision Delivery Infusion SetQuest Medical, Inc. · 2021 · Recalled

Most influential descendants

Showing 2 of 2 · See all

K142527Extension Set with BD Q-Syte Luer Access Split SeptumAcacia, Inc. · 2014 · cites it directly1descendant
K202672Precision Delivery Infusion SetQuest Medical, Inc. · 2021 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970855	Clave Connector	Icu Medical, Inc.	1997	52
0 (this device)	K013621	BD Saf-T PRN Luer Activated Valve, Model 385100	Becton Dickinson Infusion Therapy Systems, Inc.	2002	—
+1	K142527	Extension Set with BD Q-Syte Luer Access Split Septum	Acacia, Inc.	2014	—
+2	K202672	Precision Delivery Infusion Set	Quest Medical, Inc.	2021	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2021	1	0

FIG. 1 — Lineage of K013621, 1997–2021Source: 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? (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
*	K970855	Clave Connector Summary page 1 …9 October 25, 2001 BD Saf-T PRN Luer Activated Valve Luer Activated Valve Accessory to an Intravascular Administration Set Clave® Connector C-1000 \|ICU Medical Inc. K970855 Description of the BD Saf-T PRN Luer Activated Valve: The BD Saf-T PRN Luer Activated Valve is a closed system that opens when…	Icu Medical, Inc.	1997	52

Also cleared against K970855: 14 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K142527	Extension Set with BD Q-Syte Luer Access Split Septum	Acacia, Inc.	2014	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 19, 2015	Class II	Z-1317-2015	Process control	Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum.
Nov 6, 2009	Not classified	Z-1075-2010	Nonconforming Material/Component	Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
Nov 6, 2009	Not classified	Z-1073-2010	Nonconforming Material/Component	Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
Nov 6, 2009	Not classified	Z-1074-2010	Nonconforming Material/Component	Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
Oct 19, 2009	Not classified	Z-0751-2010	Process control	Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
Oct 19, 2009	Not classified	Z-0754-2010	Process control	Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
Oct 19, 2009	Not classified	Z-0755-2010	Process control	Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
Oct 19, 2009	Not classified	Z-0753-2010	Process control	Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
Oct 19, 2009	Not classified	Z-0756-2010	Process control	Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
Oct 19, 2009	Not classified	Z-0752-2010	Process control	Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
Oct 19, 2009	Not classified	Z-0750-2010	Process control	Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.

The 5 latest of 11 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K142527 (Acacia, Inc., 2014) has gone furthest, with 1 descendant of its own.
14 other devices also cite its predicate K970855.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

An intravascular administration set is a device used to administer fluids from a container to a patient’s vascular system through a needle or catheter. An administration set may include the needle or catheter, tubing, flow regulator, drip chamber, infusion line filter, 1V set stopcock, fluid delivery tubing, connectors between parts of the set, side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an IV~ bag or other infusion fluid container.

The BD Saf-T PRN Luer Activated Valve needleless connector is an accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.

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/K013621 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013621: BD Saf-T PRN Luer Activated Valve, Model 385100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013621

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026