510(k) · Cleared

Cleared

Terumo Micro Tapered Pen Needle

K052561510(k) TraditionalCleared Nov 23, 200565-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

Kofu Factory of Terumo Corp. · FMI Needle, Hypodermic, Single Lumen

Cleared on Nov 23, 2005 as substantially equivalent to K002938 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 2000) and 1 other predicate after a 65-day review. Its family tree reaches back 1 generation to 1996. 17 later devices descend from it.

Decided: Nov 23, 2005
Review: 65 days
Class: Class II
Product code: FMI
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K955235 (1996). 2 ancestors in all. 17 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK955235 B-D Ultra Fine II, Micro Fine + Short Needle Insulin SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1996 · Recalled
This deviceK052561 Terumo Micro Tapered Pen NeedleKofu Factory of Terumo Corp. · 2005
Descendant · cites it directly · 11 of its ownK063466 Top FineDaejin Tech Medical Manufacturing Co., Ltd. · 2007
Descendant · 2 generations on · 9 of its ownK100812 Ulticare Disposable Pen NeedlesUltimed, Inc. · 2010
Descendant · cites it directly · 4 of its ownK140516 Terumo Pen Injector Needle 34Kofu Factory of Terumo Corp. · 2014
Descendant · 3 generations on · 4 of its ownK113186 Sterile Insulin Pen NeedleShina Corp. · 2012
Descendant · 3 generations on · 3 of its ownK133100 Carefine Pen NeedleFacet Technologies · 2014

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2007high 4 (2014) · low 0 (2008)2026

Most influential descendants

Showing 5 of 17 · See all

K063466Top FineDaejin Tech Medical Manufacturing Co., Ltd. · 2007 · cites it directly11descendants
K100812Ulticare Disposable Pen NeedlesUltimed, Inc. · 2010 · 2 generations on9descendants
K140516Terumo Pen Injector Needle 34Kofu Factory of Terumo Corp. · 2014 · cites it directly4descendants
K113186Sterile Insulin Pen NeedleShina Corp. · 2012 · 3 generations on4descendants
K133100Carefine Pen NeedleFacet Technologies · 2014 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K955235	B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe	Bd Becton Dickinson Vacutainer Systems Preanalytic	1996	1
0 (this device)	K052561	Terumo Micro Tapered Pen Needle	Kofu Factory of Terumo Corp.	2005	—
+1	K063466	Top Fine	Daejin Tech Medical Manufacturing Co., Ltd.	2007	—
+2	K100812	Ulticare Disposable Pen Needles	Ultimed, Inc.	2010	—
+1	K140516	Terumo Pen Injector Needle 34	Kofu Factory of Terumo Corp.	2014	—
+3	K113186	Sterile Insulin Pen Needle	Shina Corp.	2012	—
+3	K133100	Carefine Pen Needle	Facet Technologies	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2010	1	0
2012	1	0
2014	4	0
2016	2	0
2017	1	0
2020	2	0
2022	1	0
2023	1	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K052561, 1996–2026Source: 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? (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
*	K002938	B-D Ultra-Fine Iii Pen Needle; Model 31G X 3/16 Summary page 2 …d by Terumo Corporation in Japan is substantially equivalent to the legally marketed Becton Dickinson Ultra-fine 3Ig x 3/16" (5mm) pen needle cleared under K002938 and the Becton Dickinson Ultra-fine 31g x 5/16" (8mm) pen needle cleared under K955235. Differences between the de…	Bd Becton Dickinson Vacutainer Systems Preanalytic	2000	—
*	K955235	B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe Summary page 2 …cton Dickinson Ultra-fine 3Ig x 3/16" (5mm) pen needle cleared under K002938 and the Becton Dickinson Ultra-fine 31g x 5/16" (8mm) pen needle cleared under K955235. Differences between the devices do not raise any significant issues of safety or effectiveness. Terumo's…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1996	1

Also cleared against K002938: 4 other devices →

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K063466	Top Fine	Daejin Tech Medical Manufacturing Co., Ltd.	2007	11
K140516	Terumo Pen Injector Needle 34	Kofu Factory of Terumo Corp.	2014	4

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K063466 (Daejin Tech Medical Manufacturing Co., Ltd., 2007) has gone furthest, with 11 descendants of its own.
4 other devices also cite its predicate K002938.

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?

The TERUMO® Micro tapered pen needle is intended for use with a pen injector device for the subcutaneous injection of insulin. It is indicated for general use and for pediatric patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052561 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052561: Terumo Micro Tapered 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/K052561

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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