510(k) · Cleared

Cleared

B-D Ultra-Fine II Short 31G X 5/16 Pen Needle

K970737510(k) TraditionalCleared Mar 28, 199728-day reviewClass II21 CFR 880.5570

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 Mar 28, 1997 after a 28-day review. The FDA summary names its predicate without a number. 120 later devices descend from it.

Decided: Mar 28, 1997
Review: 28 days
Class: Class II
Product code: FMI
Recalls: None
Predicates: 0

120 later devices descend from it, 2 citing it directly.

This deviceK970737 B-D Ultra-Fine II Short 31G X 5/16 Pen NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1997
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 · 3 generations on · 78 of its ownK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008
Descendant · 4 generations on · 36 of its ownK110421 Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011
Descendant · 3 generations on · 31 of its ownK112057 KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011

Showing 5 of 120 descendants. See all descendants

Descendants cleared per year

1998high 19 (2022) · low 0 (2000)2026

Most influential descendants

Showing 5 of 120 · See all

K021475BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · cites it directly100descendants
K070440BD Hypoint NeedleBecton, Dickinson & CO · 2007 · 2 generations on91descendants
K072739Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008 · 3 generations on78descendants
K110421Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011 · 4 generations on36descendants
K112057KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011 · 3 generations on31descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K970737	B-D Ultra-Fine II Short 31G X 5/16 Pen Needle	Bd Becton Dickinson Vacutainer Systems Preanalytic	1997	—
+1	K021475	BD Single Lumen Needle, Syringe and Blood Collection Set	Bd	2002	3
+2	K070440	BD Hypoint Needle	Becton, Dickinson & CO	2007	—
+3	K072739	Jierui Syringes and Needles	Shandong Weigao Group Medical Polymer Co., Ltd.	2008	—
+4	K110421	Disposable Insulin Syringe	Wenzhou Wuzhou Import & Export Co., Ltd.	2011	—
+3	K112057	KDL Syringes and Needle	Shanghai Kindly Enterprise Dev. Group Co.,	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0
2001	1	0
2002	1	0
2007	2	0
2008	1	0
2009	1	0
2010	4	0
2011	4	0
2012	4	0
2013	6	0
2014	1	0
2015	4	0
2016	4	0
2017	5	0
2018	3	0
2019	4	0
2020	6	0
2021	13	0
2022	19	0
2023	17	0
2024	6	0
2025	7	0
2026	5	0

FIG. 1 — Lineage of K970737, 1997–2026Source: 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? (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
*	—	B-D 30g x 5/16” pen needle Named without a submission number			—

What descends from it? (120)

See all 120

2 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
K982399	Disetronic Penfine Injection Pen Needle	Disetronic Medical Systems	1998	18

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

No FDA recall names this device.

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)	—

What is it indicated for?

for use with a pen injector device for the subcutaneous injection of insulin.

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/K970737 · printed Nov 6, 2026

Cite this page

510(k) Report. “K970737: B-D Ultra-Fine II Short 31G X 5/16 Pen Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970737

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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