510(k) · Cleared

Recalled · Class II · 2017

BD Insulin Syringe

K024112510(k) SpecialCleared Jan 9, 200327-day reviewClass II21 CFR 880.5860Recalls 3

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

Becton, Dickinson & CO · FMF Syringe, Piston

Cleared on Jan 9, 2003 as substantially equivalent to K941657 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1994) and 1 other predicate after a 27-day review. Its family tree reaches back 1 generation to 1994. 37 later devices descend from it. It has been recalled 3 times.

Decided: Jan 9, 2003
Review: 27 days
Class: Class II
Product code: FMF
Recalls: 3
Predicates: 2

Its longest line of descent runs back 1 generation to K941657 (1994). 2 ancestors in all. 37 later devices descend from it, 11 citing it directly.

By dateBy generation

Root · 1 generation backK941657 BD Micro Fine, Ultra Fine, and Allergy SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
This deviceK024112 BD Insulin SyringeBecton, Dickinson & CO · 2003
Descendant · cites it directly · 10 of its ownK040036 Inviro Snap Safety Insulin Syringe, 1 CC, Model 102905Inviro Medical · 2004
Descendant · 2 generations on · 8 of its ownK050131 Insosafe Bak'snap Retractable Insulin Safety SyringeM.K. Meditech Co., Ltd. · 2005
Descendant · cites it directly · 6 of its ownK062702 Ulticare Disposable Syringes and NeedlesUltimed, Inc. · 2006 · Recalled
Descendant · 3 generations on · 5 of its ownK152808 U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd. · 2016
Descendant · 2 generations on · 5 of its ownK070917 Feel-Ject Insulin SyringeFeel Tech · 2007 · Recalled

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

2003high 5 (2016) · low 0 (2013)2026

Most influential descendants

Showing 5 of 37 · See all

K040036Inviro Snap Safety Insulin Syringe, 1 CC, Model 102905Inviro Medical · 2004 · cites it directly10descendants
K050131Insosafe Bak'snap Retractable Insulin Safety SyringeM.K. Meditech Co., Ltd. · 2005 · 2 generations on8descendants
K062702Ulticare Disposable Syringes and NeedlesUltimed, Inc. · 2006 · cites it directly6descendants
K152808U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd. · 2016 · 3 generations on5descendants
K070917Feel-Ject Insulin SyringeFeel Tech · 2007 · 2 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K941657	BD Micro Fine, Ultra Fine, and Allergy Syringe	Bd Becton Dickinson Vacutainer Systems Preanalytic	1994	—
0 (this device)	K024112	BD Insulin Syringe	Becton, Dickinson & CO	2003	—
+1	K040036	Inviro Snap Safety Insulin Syringe, 1 CC, Model 102905	Inviro Medical	2004	—
+2	K050131	Insosafe Bak'snap Retractable Insulin Safety Syringe	M.K. Meditech Co., Ltd.	2005	—
+1	K062702	Ulticare Disposable Syringes and Needles	Ultimed, Inc.	2006	1
+3	K152808	U&U Insulin Syringe with/without Safety Retractable Device	U&U Medical Technology Co, Ltd.	2016	—
+2	K070917	Feel-Ject Insulin Syringe	Feel Tech	2007	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0
2005	1	0
2006	1	0
2007	4	0
2008	1	0
2009	3	0
2010	1	0
2011	1	0
2012	2	0
2015	1	0
2016	5	0
2017	1	0
2019	2	0
2020	3	0
2021	1	0
2022	3	0
2023	2	0
2024	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K024112, 1994–2026Source: 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 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 16.2 · 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? (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
*	K941657	BD Micro Fine, Ultra Fine, and Allergy Syringe Summary page 1 …and Ultra-FineTM I1 Common Names: Insulin Syringe Classification Name: Piston Syringe 3. Predicate Device: BD Insulin Syringe - K941657 and K955235 Manufactured by: Becton Dickinson Consumer Healthcare 4. Device Description: The BD Insulin Syringes -…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1994	—
*	K955235	B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe Summary page 1 …neTM I1 Common Names: Insulin Syringe Classification Name: Piston Syringe 3. Predicate Device: BD Insulin Syringe - K941657 and K955235 Manufactured by: Becton Dickinson Consumer Healthcare 4. Device Description: The BD Insulin Syringes - Ultra-FineT…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1996	1

Also cleared against K941657: 7 other devices →

What descends from it? (37)

See all 37

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

Number	Device	Applicant	Decided	Descendants
K040036	Inviro Snap Safety Insulin Syringe, 1 CC, Model 102905	Inviro Medical	2004	10
K062702	Ulticare Disposable Syringes and Needles	Ultimed, Inc.	2006	6
K091167	Shina Insulin Syringe-Including Accu-Sure Insulin Syringes	Shina Corp.	2009	4
K170386	BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes…	Becton Dickinson & Company	2017	3
K071459	B. Braun Piston Syringes and Omnican and Omnifix Insulin Syringes	B.Braun Medical, Inc.	2007	3
K162081	BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD…	Becton, Dickinson and Company	2016	1
K063348	Top Fine Insulin Syringe	Daejin Tech Medical Manufacturing Co., Ltd.	2007	1
K151870	BD U-500 Insulin Syringe	Becton, Dickinson and Company	2016	0
K110882	Imc Insulin Syringe	International Medsurg Connection	2011	0
K081547	Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CC	Bio-Med USA, Inc.	2008	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 25, 2017	Class II	Z-0183-2018	Labeling mix-ups	Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle mL 12.7mm 30G, Cat (Ref) 328466, was found to have some polybags in the lot incorrectly labeled as BD Ultra-Fine needle mL 8mm 31G, Cat (Ref) 328468.…
Jun 15, 2011	Not classified	Z-0174-2012	Labeling mix-ups	Experiment labels may be on shelf cartons of 1.0ml 28G x 1/2 blister packaged insulin syringes.
Jun 21, 2007	Not classified	Z-1226-2007	Other	Complaints received indicating open seals on blister paks, potentially compromising the sterility of the product.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K040036 (Inviro Medical, 2004) has gone furthest, with 10 descendants of its own.
7 other devices also cite its predicate K941657.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

Becton Dickinson insulin syringes are intended for subcutaneous injection of insulins.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024112 · printed Nov 3, 2026

Cite this page

510(k) Report. “K024112: BD Insulin Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024112

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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