510(k) · Cleared

Recalled · 2004

B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe

K955235510(k) TraditionalCleared Feb 12, 199690-day reviewClass II21 CFR 880.5570Recalls 1

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

Bd Becton Dickinson Vacutainer Systems Preanalytic · FMI Needle, Hypodermic, Single Lumen

Cleared on Feb 12, 1996 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 153 later devices descend from it. It has been recalled once.

Decided: Feb 12, 1996
Review: 90 days
Class: Class II
Product code: FMI
Recalls: 1
Predicates: 0

153 later devices descend from it, 10 citing it directly.

This deviceK955235 B-D Ultra Fine II, Micro Fine + Short Needle Insulin SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1996
Descendant · cites it directly · 100 of its ownK021475 BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · Recalled
Descendant · 2 generations on · 91 of its ownK070440 BD Hypoint NeedleBecton, Dickinson & CO · 2007
Descendant · cites it directly · 84 of its ownK992802 Terumo U-100 Insulin SyringeTerumo Medical Corp. · 1999
Descendant · cites it directly · 82 of its ownK071630 Terumo 31G Thinpro Insulin SyringeTerumo Medical Corp. · 2007
Descendant · 2 generations on · 78 of its ownK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008

Showing 5 of 153 descendants. See all descendants

Descendants cleared per year

1999high 18 (2022) · low 0 (2000)2026

Most influential descendants

Showing 5 of 153 · See all

K021475BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · cites it directly100descendants
K070440BD Hypoint NeedleBecton, Dickinson & CO · 2007 · 2 generations on91descendants
K992802Terumo U-100 Insulin SyringeTerumo Medical Corp. · 1999 · cites it directly84descendants
K071630Terumo 31G Thinpro Insulin SyringeTerumo Medical Corp. · 2007 · cites it directly82descendants
K072739Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008 · 2 generations on78descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K955235	B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe	Bd Becton Dickinson Vacutainer Systems Preanalytic	1996	—
+1	K021475	BD Single Lumen Needle, Syringe and Blood Collection Set	Bd	2002	3
+2	K070440	BD Hypoint Needle	Becton, Dickinson & CO	2007	—
+1	K992802	Terumo U-100 Insulin Syringe	Terumo Medical Corp.	1999	—
+1	K071630	Terumo 31G Thinpro Insulin Syringe	Terumo Medical Corp.	2007	—
+2	K072739	Jierui Syringes and Needles	Shandong Weigao Group Medical Polymer Co., Ltd.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	2	0
2002	1	0
2003	2	0
2004	1	0
2005	2	0
2006	1	0
2007	8	0
2008	2	0
2009	4	0
2010	4	0
2011	5	0
2012	4	0
2013	4	0
2014	5	0
2015	3	0
2016	9	0
2017	8	0
2018	3	0
2019	5	0
2020	8	0
2021	13	0
2022	18	0
2023	18	0
2024	7	0
2025	10	0
2026	6	0

FIG. 1 — Lineage of K955235, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (153)

See all 153

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

Number	Device	Applicant	Decided	Descendants
K021475	BD Single Lumen Needle, Syringe and Blood Collection Set	Bd	2002	100
K992802	Terumo U-100 Insulin Syringe	Terumo Medical Corp.	1999	84
K071630	Terumo 31G Thinpro Insulin Syringe	Terumo Medical Corp.	2007	82
K024112	BD Insulin Syringe	Becton, Dickinson & CO	2003	37
K052561	Terumo Micro Tapered Pen Needle	Kofu Factory of Terumo Corp.	2005	17
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
K991758	Monoject Insulin Syringe	The Kendal Co.	1999	3
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
Oct 22, 2004	Not classified	Z-0569-05	Other	Syringes labeled as 5/16 inch product (30 ga) actually contained the 1/2 inch product (28 ga).

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K021475 (Bd, 2002) has gone furthest, with 100 descendants of its own.

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)	—

https://510kreport.com/device/K955235 · printed Nov 6, 2026

Cite this page

510(k) Report. “K955235: B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955235

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026