510(k) · Cleared

Recalled · Class II · 2026

BD Single Use, Hypodermic Syringe

K110771510(k) SpecialCleared May 13, 201153-day reviewClass II21 CFR 880.5860Recalls 10

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

Becton, Dickinson and Company · FMF Syringe, Piston

Cleared on May 13, 2011 as substantially equivalent to K980987 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1998) after a 53-day review. Its family tree reaches back 1 generation to 1998. 17 later devices descend from it. It has been recalled 10 times.

Decided: May 13, 2011
Review: 53 days
Class: Class II
Product code: FMF
Recalls: 10
Predicates: 1

Its longest line of descent runs back 1 generation to K980987 (1998). 17 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 1 generation backK980987 Becton Dickinson SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · Recalled
This deviceK110771 BD Single Use, Hypodermic SyringeBecton, Dickinson and Company · 2011
Descendant · cites it directly · 2 of its ownK143757 ANUTRA Feedback Aspiration SyringeAnutra Medical, Inc. · 2015
Descendant · cites it directly · 2 of its ownK132553 U&U Sterile Piston Syringe Without NeedleU&U Medical Technology Co, Ltd. · 2014 · Recalled
Descendant · cites it directly · 2 of its ownK113241 BD Emerald Single Use, Hypodermic SyringeBecton Dickinson · 2011
Descendant · 2 generations on · 1 of its ownK201816 ArthrotapAccuro Technologies, Inc. · 2020
Descendant · 2 generations on · 1 of its ownK191642 TK Sterile Piston Syringe without NeedleAnhui Tiankang Medical Technology Co., Ltd. · 2020

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2011high 3 (2017) · low 0 (2018)2026

Most influential descendants

Showing 5 of 17 · See all

K143757ANUTRA Feedback Aspiration SyringeAnutra Medical, Inc. · 2015 · cites it directly2descendants
K132553U&U Sterile Piston Syringe Without NeedleU&U Medical Technology Co, Ltd. · 2014 · cites it directly2descendants
K113241BD Emerald Single Use, Hypodermic SyringeBecton Dickinson · 2011 · cites it directly2descendants
K201816ArthrotapAccuro Technologies, Inc. · 2020 · 2 generations on1descendant
K191642TK Sterile Piston Syringe without NeedleAnhui Tiankang Medical Technology Co., Ltd. · 2020 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K980987	Becton Dickinson Syringe	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998	15
0 (this device)	K110771	BD Single Use, Hypodermic Syringe	Becton, Dickinson and Company	2011	—
+1	K143757	ANUTRA Feedback Aspiration Syringe	Anutra Medical, Inc.	2015	—
+1	K132553	U&U Sterile Piston Syringe Without Needle	U&U Medical Technology Co, Ltd.	2014	1
+1	K113241	BD Emerald Single Use, Hypodermic Syringe	Becton Dickinson	2011	—
+2	K201816	Arthrotap	Accuro Technologies, Inc.	2020	—
+2	K191642	TK Sterile Piston Syringe without Needle	Anhui Tiankang Medical Technology Co., Ltd.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	1	0
2013	2	0
2014	2	0
2015	1	0
2016	1	0
2017	3	0
2020	2	0
2021	1	0
2023	2	0
2025	1	0

FIG. 1 — Lineage of K110771, 1998–2025Source: 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 FMF? 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 FMF device

#1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 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
*	K980987	Becton Dickinson Syringe Summary page 1 …Trade Name: Becton Dickinson Single Use Hypodermic Syringe Manufacturer: Becton, Dickinson and Company 510O(k) Number: K980987 4. Device Description: The modified BD Single Use, Hypodermic Syringe is a three-piece single use, hypoder…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998	15

Also cleared against K980987: 17 other devices →

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K143757	ANUTRA Feedback Aspiration Syringe	Anutra Medical, Inc.	2015	2
K132553	U&U Sterile Piston Syringe Without Needle	U&U Medical Technology Co, Ltd.	2014	2
K113241	BD Emerald Single Use, Hypodermic Syringe	Becton Dickinson	2011	2
K171362	Merit Syringe	Merit Medical Systems, Inc.	2017	1
K162057	ConceptoMed Luer-Jack Slip 10ml	Conceptomed AS	2017	1
K153553	SiO2 Coated syringe 3 ml	Sio2 Medical Products	2016	0
K132011	Apoteca Dug Compounding Dosing Device,Apoteca I.V. Transfer Set	Aea Srl	2014	0
K130230	Sterile Piston Hypodermic Syringes (with/Without Needle), Hypodermic Needles	Wuxi Yushou Medical Applicances Co., Ltd.	2013	0
K130212	Safety Hypodermic Needles with/Without Syringe	Wuxi Yushou Medical Applicances Co., Ltd.	2013	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 28, 2026	Class II	Z-2614-2026	Process control	A single lot of expired syringes were distributed due to a distribution system control failure.
Sep 16, 2016	Class II	Z-2752-2017	Process control	BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
Sep 16, 2016	Class II	Z-2751-2017	Process control	BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required of 10-6.
Sep 16, 2016	Class II	Z-2750-2017	Process control	BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
Sep 16, 2016	Class II	Z-2747-2017	Process control	BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
Sep 16, 2016	Class II	Z-2749-2017	Process control	BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
Sep 16, 2016	Class II	Z-2753-2017	Process control	BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
Mar 25, 2016	Class II	Z-1936-2016	Error in labeling	BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.
Mar 25, 2016	Class II	Z-1937-2016	Error in labeling	BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.
Dec 19, 2014	Class II	Z-1055-2015	Device Design	The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe.

The 5 latest of 10 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, K143757 (Anutra Medical, Inc., 2015) has gone furthest, with 2 descendants of its own.
17 other devices also cite its predicate K980987.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · FMF

13in 2025

2007high 24 (2022) · low 8 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMF

114in 2025

2007high 239 (2026) · low 74 (2008)2026

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

Recalls per year · FMF

19in 2023

2007high 19 (2023) · low 0 (2016)2026

Class I (19 since 2007) Class II/III not classified

Adverse event reports per year · FMF

4,181in 2025

2007high 5,874 (2021) · low 186 (2011)2025

MAUDE reports naming product code FMF, 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	23	90	6	674
2008	9	74	11	691
2009	14	94	15	913
2010	11	130	12	679
2011	16	109	3	186
2012	9	86	6	307
2013	12	154	1	326
2014	13	84	1	244
2015	11	87	2	273
2016	12	146	0	684
2017	13	135	3	1,858
2018	8	87	2	3,952
2019	11	146	1	5,863
2020	15	107	2	5,334
2021	20	175	1	5,874
2022	24	211	2	5,233
2023	22	173	19 (18)	5,214
2024	14	130	0	5,122
2025	13	114	0	4,181
2026	9	239	2 (1)	—

What is it indicated for?

The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K110771 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110771: BD Single Use, Hypodermic Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110771

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