510(k) · Cleared

Cleared

Novofine Plus 32G 4 MM

K133738510(k) TraditionalCleared May 21, 2014163-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 May 21, 2014 as substantially equivalent to K090111 (Novo Nordisk, Inc., 2010) and 2 other predicates after a 163-day review. Its family tree reaches back 5 generations to 1995. 2 later devices descend from it.

Decided: May 21, 2014
Review: 163 days
Class: Class II
Product code: FMI
Recalls: None
Predicates: 3

Its longest line of descent runs back 5 generations to K951254 (1995). 10 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 5 generations backK951254 Safetyglide NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1995 · Recalled
4 generations backK050106 Novofine Autocover 30G X 8MMNovo Nordisk, Inc. · 2005
3 generations backK062500 Flexpen NeedleNovo Nordisk, Inc. · 2006
2 generations backK090111 Flexpen NeedleNovo Nordisk, Inc. · 2010
1 generation backK093109 Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5')Novo Nordisk, Inc. · 2010
This deviceK133738 Novofine Plus 32G 4 MMNovo Nordisk, Inc. · 2014
Descendant · cites it directly · 1 of its ownK202005 NovoFine Plus 32G Tip x 4 mmNovo Nordisk, Inc. · 2020
Descendant · 2 generations on · 0 of its ownK231255 NovoFine® PlusNovo Nordisk, Inc. · 2023

Most influential descendants

Showing 2 of 2 · See all

K202005NovoFine Plus 32G Tip x 4 mmNovo Nordisk, Inc. · 2020 · cites it directly1descendant
K231255NovoFine® PlusNovo Nordisk, Inc. · 2023 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K951254	Safetyglide Needle	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995	4
−4	K050106	Novofine Autocover 30G X 8MM	Novo Nordisk, Inc.	2005	—
−3	K062500	Flexpen Needle	Novo Nordisk, Inc.	2006	—
−2	K090111	Flexpen Needle	Novo Nordisk, Inc.	2010	—
−1	K093109	Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5')	Novo Nordisk, Inc.	2010	—
0 (this device)	K133738	Novofine Plus 32G 4 MM	Novo Nordisk, Inc.	2014	—
+1	K202005	NovoFine Plus 32G Tip x 4 mm	Novo Nordisk, Inc.	2020	—
+2	K231255	NovoFine® Plus	Novo Nordisk, Inc.	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2005	2	0
2010	1	0
2013	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0
2023	1	0

FIG. 1 — Lineage of K133738, 1995–2023Source: 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? (3)

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
*	K090111	Flexpen Needle Summary page 2 …ubstantial Equivalence: NovoFine® Plus is a disposable needle which is substantially equivalent to Novo Nordisk's NovoFine' 32G Tip x 6 mnm needle, cleared under 510O(k) K09011 1, and NovoTwistl 320 Tip x 5mnm needle, cleared under 5 10O(k) K093 109, and to Becton Dickinson's BD Pen Needle 320 x 4 mm, clear…	Novo Nordisk, Inc.	2010	—
*	K093109	Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5') Summary page 2 …substantially equivalent to Novo Nordisk's NovoFine' 32G Tip x 6 mnm needle, cleared under 510O(k) K09011 1, and NovoTwistl 320 Tip x 5mnm needle, cleared under 5 10O(k) K093 109, and to Becton Dickinson's BD Pen Needle 320 x 4 mm, cleared under 5 10(k) K 123300. The term "substantial equivalence" as used…	Novo Nordisk, Inc.	2010	—
*	K123300	BD Pen Needle Summary page 2 …under 510O(k) K09011 1, and NovoTwistl 320 Tip x 5mnm needle, cleared under 5 10O(k) K093 109, and to Becton Dickinson's BD Pen Needle 320 x 4 mm, cleared under 5 10(k) K 123300. The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence…	Becton, Dickinson & CO	2013	—

Also cleared against K090111: 4 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K202005	NovoFine Plus 32G Tip x 4 mm	Novo Nordisk, Inc.	2020	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 19 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
1 of the 10 ancestors has a recall of any class.
Of its descendants, K202005 (Novo Nordisk, Inc., 2020) has gone furthest, with 1 descendant of its own.
4 other devices also cite its predicate K090111.

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. 2014, 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?

NovoFine® Plus needles are intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin, GLP-1 analogs, and somatropin.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K133738 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133738: Novofine Plus 32G 4 MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133738

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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