510(k) · Cleared

Recalled · Class II · 2020

BD Single Lumen Needle, Syringe and Blood Collection Set

K021475510(k) TraditionalCleared Jul 19, 200272-day reviewClass II21 CFR 880.5570Recalls 3

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

Bd · FMI Needle, Hypodermic, Single Lumen

Cleared on Jul 19, 2002 as substantially equivalent to K955235 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1996) and 7 other predicates after a 72-day review. Its family tree reaches back 1 generation to 1993. 100 later devices descend from it. It has been recalled 3 times.

Decided: Jul 19, 2002
Review: 72 days
Class: Class II
Product code: FMI
Recalls: 3
Predicates: 8

Its longest line of descent runs back 1 generation to K931367 (1993). 8 ancestors in all. 100 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 1 generation backK931367 Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
This deviceK021475 BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002
Descendant · cites it directly · 91 of its ownK070440 BD Hypoint NeedleBecton, Dickinson & CO · 2007
Descendant · 2 generations on · 78 of its ownK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008
Descendant · 3 generations on · 36 of its ownK110421 Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011
Descendant · 2 generations on · 31 of its ownK112057 KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011
Descendant · 3 generations on · 13 of its ownK190002 Sterile Hypodermic Syringe for Single use, with/without needle…Shanghai Kohope Medical Devices Co., Ltd. · 2019

Showing 5 of 100 descendants. See all descendants

Descendants cleared per year

2007high 17 (2023) · low 1 (2008)2026

Most influential descendants

Showing 5 of 100 · See all

K070440BD Hypoint NeedleBecton, Dickinson & CO · 2007 · cites it directly91descendants
K072739Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008 · 2 generations on78descendants
K110421Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011 · 3 generations on36descendants
K112057KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011 · 2 generations on31descendants
K190002Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe…Shanghai Kohope Medical Devices Co., Ltd. · 2019 · 3 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K931367	Vacutainer Brand Luer Adapter	Bd Becton Dickinson Vacutainer Systems Preanalytic	1993	—
0 (this device)	K021475	BD Single Lumen Needle, Syringe and Blood Collection Set	Bd	2002	—
+1	K070440	BD Hypoint Needle	Becton, Dickinson & CO	2007	—
+2	K072739	Jierui Syringes and Needles	Shandong Weigao Group Medical Polymer Co., Ltd.	2008	—
+3	K110421	Disposable Insulin Syringe	Wenzhou Wuzhou Import & Export Co., Ltd.	2011	—
+2	K112057	KDL Syringes and Needle	Shanghai Kindly Enterprise Dev. Group Co.,	2011	—
+3	K190002	Sterile Hypodermic Syringe for Single use, with/without needle, Sterile…	Shanghai Kohope Medical Devices Co., Ltd.	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1996	1	0
1997	3	0
2000	1	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2008	1	0
2009	1	0
2010	2	0
2011	4	0
2012	1	0
2013	4	0
2014	1	0
2015	2	0
2016	4	0
2017	5	0
2018	3	0
2019	3	0
2020	5	0
2021	13	0
2022	15	0
2023	17	0
2024	6	0
2025	7	0
2026	4	0

FIG. 1 — Lineage of K021475, 1993–2026Source: 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 FMI? 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 FMI device

#1 K252886 Pen Needlescore 14.5 · 4 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? (9)

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
*	K955235	B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe Summary page 1 …I 510(k) Number [ BD Hypodermic Needles 1 Pre-Amendment BD Ultra Fine 11, Micro Fine + Short Needle K955235 L Insulin BD Intravascula BD Pen Needles /I K002938;K970737;K9…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1996	1
*	K002938	B-D Ultra-Fine Iii Pen Needle; Model 31G X 3/16 Summary page 1 …ltra Fine 11, Micro Fine + Short Needle K955235 L Insulin BD Intravascula BD Pen Needles /I K002938;K970737;K950466 BD lntrocvte Introducers n KO1 3304 t…	Bd Becton Dickinson Vacutainer Systems Preanalytic	2000	—
*	K970737	B-D Ultra-Fine II Short 31G X 5/16 Pen Needle Summary page 1 …e 11, Micro Fine + Short Needle K955235 L Insulin BD Intravascula BD Pen Needles /I K002938;K970737;K950466 BD lntrocvte Introducers n KO1 3304 t…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1997	—
*	K950466	B-D Ultra-Fine II Pen Needle Summary page 1 …cro Fine + Short Needle K955235 L Insulin BD Intravascula BD Pen Needles /I K002938;K970737;K950466 BD lntrocvte Introducers n KO1 3304 t…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995	—
*	K013304	BD Introsyte Precision Introducer, BD Introsyte Autogaurd Shielded Introducer	Becton Dickinson Infusion Therapy Systems, Inc.	2002	—
*	K931367	Vacutainer Brand Luer Adapter Summary page 1 …2938;K970737;K950466 BD lntrocvte Introducers n KO1 3304 t K931367 K965202…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1993	—
*	K965202	Vacutainer Brand Safety-Lok Blood Collection Set Summary page 1 …n KO1 3304 t K931367 K965202 -d…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1997	—
*	K972404	Vacutainer Brand Safety Blood Collection Assembly (Multiple) Summary page 1 …K965202 -d K972404 Summary of Safety and Effectiveness 1 of 2 Eecton. Dickinson and Company === Page 2…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1997	1
*	—	BD Hypodermic Needles Named without a submission number			—

Also cleared against K955235: 9 other devices →

What descends from it? (100)

See all 100

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

Number	Device	Applicant	Decided	Descendants
K070440	BD Hypoint Needle	Becton, Dickinson & CO	2007	91
K162081	BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD…	Becton, Dickinson and Company	2016	1
K072247	Sterican Hypodermic Needles	B.Braun Medical, Inc.	2007	1
K240355	FROG (Filter Removal of Glass)	Carrtech Corp	2025	0
K163437	hypodermic Pinpoint™ GT Needle	C.R. Bard, Inc.	2017	0
K133635	Easypoint Needle	Retractable Technologies, Inc.	2014	0
K092746	Micronjet 600	Nanopass Technologies, Ltd.	2010	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 18, 2020	Class II	Z-0588-2021	Under Investigation by firm	BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2" Lot No. 9128897. The possibility of infection may be present if the blood is not noticed prior to use by the clinician.
May 31, 2017	Class II	Z-0207-2018	Process control	Hub damage resulting in breakage and/or leakage during use.
Oct 8, 2011	Not classified	Z-1009-2012	Device Design	Becton Dickinson has identified clogged needles.

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 8 ancestors have a recall of any class.
Of its descendants, K070440 (Becton, Dickinson & CO, 2007) has gone furthest, with 91 descendants of its own.
9 other devices also cite its predicate K955235.

How does its category compare?

All FMI devices

FMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMI

11in 2025

2007high 23 (2022) · low 3 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMI

141in 2025

2007high 263 (2020) · low 71 (2007)2026

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

Recalls per year · FMI

1in 2024

2007high 79 (2010) · low 0 (2016)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FMI

2,424in 2025

2007high 4,986 (2023) · low 177 (2008)2025

MAUDE reports naming product code FMI, 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	15	71	2	208
2008	10	85	4	177
2009	7	177	3	263
2010	15	119	79	249
2011	12	113	5	240
2012	17	107	1	215
2013	11	87	1	255
2014	14	155	3	287
2015	10	89	1	567
2016	20	217	0	941
2017	9	253	16	1,547
2018	20	176	0	2,398
2019	12	186	5	4,896
2020	11	263	3	4,245
2021	18	143	7	4,532
2022	23	189	0	4,885
2023	18	112	2	4,986
2024	3	90	1	4,053
2025	11	141	0	2,424
2026	12	119	1 (1)	—

What is it indicated for?

The needles are intended for general purpose fluid injection/aspiration,infusion, venipuncture to obtain blood collection and insulin injection.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021475 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021475: BD Single Lumen Needle, Syringe and Blood Collection Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021475

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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