510(k) · Cleared

Cleared

BD Pen Needle

K123300510(k) SpecialCleared Jan 18, 201387-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

Becton, Dickinson & CO · FMI Needle, Hypodermic, Single Lumen

Cleared on Jan 18, 2013 as substantially equivalent to K100005 (Becton, Dickinson and Co., 2010) and 1 other predicate after an 87-day review. Its family tree reaches back 2 generations to 2005. 20 later devices descend from it.

Decided: Jan 18, 2013
Review: 87 days
Class: Class II
Product code: FMI
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K051899 (2005). 20 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK051899 BD Pen NeedleBecton, Dickinson & CO · 2005
1 generation backK100005 BD Pen NeedleBecton, Dickinson and Co. · 2010
This deviceK123300 BD Pen NeedleBecton, Dickinson & CO · 2013
Descendant · cites it directly · 11 of its ownK131358 BD Pen NeedleBecton, Dickinson & CO · 2013
Descendant · 2 generations on · 10 of its ownK162516 BD Pen NeedleBecton, Dickinson and Company · 2016 · Recalled
Descendant · cites it directly · 4 of its ownK140516 Terumo Pen Injector Needle 34Kofu Factory of Terumo Corp. · 2014
Descendant · 3 generations on · 3 of its ownK171982 Droplet Pen NeedleHtl-Strefa S.A · 2018
Descendant · 2 generations on · 2 of its ownK192082 Droplet Pen Needle 34GHtl-Strefa S.A · 2020

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2013high 4 (2020) · low 0 (2015)2026

Most influential descendants

Showing 5 of 20 · See all

K131358BD Pen NeedleBecton, Dickinson & CO · 2013 · cites it directly11descendants
K162516BD Pen NeedleBecton, Dickinson and Company · 2016 · 2 generations on10descendants
K140516Terumo Pen Injector Needle 34Kofu Factory of Terumo Corp. · 2014 · cites it directly4descendants
K171982Droplet Pen NeedleHtl-Strefa S.A · 2018 · 3 generations on3descendants
K192082Droplet Pen Needle 34GHtl-Strefa S.A · 2020 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K051899	BD Pen Needle	Becton, Dickinson & CO	2005	—
−1	K100005	BD Pen Needle	Becton, Dickinson and Co.	2010	—
0 (this device)	K123300	BD Pen Needle	Becton, Dickinson & CO	2013	—
+1	K131358	BD Pen Needle	Becton, Dickinson & CO	2013	—
+2	K162516	BD Pen Needle	Becton, Dickinson and Company	2016	2
+1	K140516	Terumo Pen Injector Needle 34	Kofu Factory of Terumo Corp.	2014	—
+3	K171982	Droplet Pen Needle	Htl-Strefa S.A	2018	—
+2	K192082	Droplet Pen Needle 34G	Htl-Strefa S.A	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2014	2	0
2016	1	0
2018	2	0
2020	4	0
2021	3	0
2022	2	0
2023	3	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K123300, 2005–2026Source: 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

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
*	K100005	BD Pen Needle Summary page 1 …, Hypodermic, Single Lumen Classification: Class 11, 21 CFR 880.5570 EMI 3. Predicate Device: RD Pen Needle- K100005 and K05 1899 Manufactured by: Becton, Dickinson and Company 4. Device Description: BD…	Becton, Dickinson and Co.	2010	—
*	K051899	BD Pen Needle Summary page 1 …, Single Lumen Classification: Class 11, 21 CFR 880.5570 EMI 3. Predicate Device: RD Pen Needle- K100005 and K05 1899 Manufactured by: Becton, Dickinson and Company 4. Device Description: BD pen needles a…	Becton, Dickinson & CO	2005	—

Also cleared against K100005: 9 other devices →

What descends from it? (20)

See all 20

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

Number	Device	Applicant	Decided	Descendants
K131358	BD Pen Needle	Becton, Dickinson & CO	2013	11
K140516	Terumo Pen Injector Needle 34	Kofu Factory of Terumo Corp.	2014	4
K133738	Novofine Plus 32G 4 MM	Novo Nordisk, Inc.	2014	2

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?

The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K131358 (Becton, Dickinson & CO, 2013) has gone furthest, with 11 descendants of its own.
9 other devices also cite its predicate K100005.

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. 2013, this device’s year, is highlighted.

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?

BD Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123300 · printed Nov 5, 2026

Cite this page

510(k) Report. “K123300: BD Pen Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123300

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