510(k) · Cleared

Cleared

Flexpen Needle

K090111510(k) TraditionalCleared Feb 1, 2010381-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

Novo Nordisk, Inc. · FMI Needle, Hypodermic, Single Lumen

Cleared on Feb 1, 2010 as substantially equivalent to K062500 (Novo Nordisk, Inc., 2006) and 3 other predicates after a 381-day review. Its family tree reaches back 3 generations to 1995. 16 later devices descend from it.

Decided: Feb 1, 2010
Review: 381 days
Class: Class II
Product code: FMI
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K951254 (1995). 6 ancestors in all. 16 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 3 generations backK951254 Safetyglide NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1995 · Recalled
2 generations backK050106 Novofine Autocover 30G X 8MMNovo Nordisk, Inc. · 2005
1 generation backK062500 Flexpen NeedleNovo Nordisk, Inc. · 2006
This deviceK090111 Flexpen NeedleNovo Nordisk, Inc. · 2010
Descendant · cites it directly · 4 of its ownK113186 Sterile Insulin Pen NeedleShina Corp. · 2012
Descendant · cites it directly · 4 of its ownK093109 Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5')Novo Nordisk, Inc. · 2010
Descendant · cites it directly · 3 of its ownK133100 Carefine Pen NeedleFacet Technologies · 2014
Descendant · cites it directly · 2 of its ownK133738 Novofine Plus 32G 4 MMNovo Nordisk, Inc. · 2014
Descendant · 2 generations on · 1 of its ownK210748 Well-life TM Pen Needles, Well-life TM Safety Pen NeedlesW. L. Med Co., Ltd. · 2022

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2010high 4 (2014) · low 0 (2011)2026

Most influential descendants

Showing 5 of 16 · See all

K113186Sterile Insulin Pen NeedleShina Corp. · 2012 · cites it directly4descendants
K093109Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5')Novo Nordisk, Inc. · 2010 · cites it directly4descendants
K133100Carefine Pen NeedleFacet Technologies · 2014 · cites it directly3descendants
K133738Novofine Plus 32G 4 MMNovo Nordisk, Inc. · 2014 · cites it directly2descendants
K210748Well-life TM Pen Needles, Well-life TM Safety Pen NeedlesW. L. Med Co., Ltd. · 2022 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K951254	Safetyglide Needle	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995	4
−2	K050106	Novofine Autocover 30G X 8MM	Novo Nordisk, Inc.	2005	—
−1	K062500	Flexpen Needle	Novo Nordisk, Inc.	2006	—
0 (this device)	K090111	Flexpen Needle	Novo Nordisk, Inc.	2010	—
+1	K113186	Sterile Insulin Pen Needle	Shina Corp.	2012	—
+1	K093109	Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5')	Novo Nordisk, Inc.	2010	—
+1	K133100	Carefine Pen Needle	Facet Technologies	2014	—
+1	K133738	Novofine Plus 32G 4 MM	Novo Nordisk, Inc.	2014	—
+2	K210748	Well-life TM Pen Needles, Well-life TM Safety Pen Needles	W. L. Med Co., Ltd.	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2005	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2012	2	0
2014	4	0
2016	1	0
2017	1	0
2018	1	0
2020	1	0
2021	1	0
2022	1	0
2023	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K090111, 1995–2026Source: 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? (4)

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
*	K062500	Flexpen Needle Summary page 1 ….5570) Class: Class II (3) SUBSTANTIAL EQUIVALENCE: FlexPene needle is a disposable needle which is substantially equivalent to K062500 cleared on November 21, 2006, NovoFine® 32G Tip (0.23/ 0.25 mm) x 6 mm disposable needle, cleared under 5 10(k) K053470,…	Novo Nordisk, Inc.	2006	—
*	K053470	Novofine 32G Tip Summary page 1 …edle which is substantially equivalent to K062500 cleared on November 21, 2006, NovoFine® 32G Tip (0.23/ 0.25 mm) x 6 mm disposable needle, cleared under 5 10(k) K053470, NovoFinev Autocovere 30G x 8 mm, cleared under 5 10(k) K050106, and to the Becton Dickinson BD Pen Needle (29G, 30OG, 3 1G)…	Novo Nordisk, Inc.	2005	—
*	K050106	Novofine Autocover 30G X 8MM Summary page 1 …November 21, 2006, NovoFine® 32G Tip (0.23/ 0.25 mm) x 6 mm disposable needle, cleared under 5 10(k) K053470, NovoFinev Autocovere 30G x 8 mm, cleared under 5 10(k) K050106, and to the Becton Dickinson BD Pen Needle (29G, 30OG, 3 1G) x (5 mm, 8 mm, 12.7 mm), cleared under 5 10(k) KO051899.…	Novo Nordisk, Inc.	2005	—
*	K051899	BD Pen Needle Summary page 1 …utocovere 30G x 8 mm, cleared under 5 10(k) K050106, and to the Becton Dickinson BD Pen Needle (29G, 30OG, 3 1G) x (5 mm, 8 mm, 12.7 mm), cleared under 5 10(k) KO051899. The term "substantial equivalence" as used in this 5 10(k) notification is limited to the definition of. substantial eq…	Becton, Dickinson & CO	2005	—

Also cleared against K062500: 2 other devices →

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K113186	Sterile Insulin Pen Needle	Shina Corp.	2012	4
K093109	Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5')	Novo Nordisk, Inc.	2010	4
K133100	Carefine Pen Needle	Facet Technologies	2014	3
K133738	Novofine Plus 32G 4 MM	Novo Nordisk, Inc.	2014	2
K173479	NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)	Novo Nordisk, Inc.	2018	1

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 15 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
1 of the 6 ancestors has a recall of any class.
Of its descendants, K113186 (Shina Corp., 2012) has gone furthest, with 4 descendants of its own.
2 other devices also cite its predicate K062500.

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. 2010, 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?

FlexPen® needles are intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide, and somatropin.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090111 · printed Nov 4, 2026

Cite this page

510(k) Report. “K090111: Flexpen Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090111

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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