510(k) · Cleared

Cleared

Clickfine Pen Needle

K122971510(k) SpecialCleared Oct 25, 201229-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

P/L Biomedical · FMI Needle, Hypodermic, Single Lumen

Cleared on Oct 25, 2012 as substantially equivalent to K102108 (Ypsomed AG, 2010) after a 29-day review. Its family tree reaches back 4 generations to 1997. 2 later devices descend from it.

Decided: Oct 25, 2012
Review: 29 days
Class: Class II
Product code: FMI
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K970737 (1997). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK970737 B-D Ultra-Fine II Short 31G X 5/16 Pen NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1997
3 generations backK982399 Disetronic Penfine Injection Pen NeedleDisetronic Medical Systems · 1998
2 generations backK994197 Disentronic Penfine Injection Pen NeedleDisetronic Medical Systems · 1999
1 generation backK102108 Clickfine Pen NeedleYpsomed AG · 2010
This deviceK122971 Clickfine Pen NeedleP/L Biomedical · 2012
Descendant · cites it directly · 1 of its ownK131125 Clickfine Pen NeedleYpsomed AG · 2013
Descendant · 2 generations on · 0 of its ownK150662 Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names…Ypsomed AG · 2015

Most influential descendants

Showing 2 of 2 · See all

K131125Clickfine Pen NeedleYpsomed AG · 2013 · cites it directly1descendant
K150662Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)Ypsomed AG · 2015 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K970737	B-D Ultra-Fine II Short 31G X 5/16 Pen Needle	Bd Becton Dickinson Vacutainer Systems Preanalytic	1997	—
−3	K982399	Disetronic Penfine Injection Pen Needle	Disetronic Medical Systems	1998	—
−2	K994197	Disentronic Penfine Injection Pen Needle	Disetronic Medical Systems	1999	—
−1	K102108	Clickfine Pen Needle	Ypsomed AG	2010	—
0 (this device)	K122971	Clickfine Pen Needle	P/L Biomedical	2012	—
+1	K131125	Clickfine Pen Needle	Ypsomed AG	2013	—
+2	K150662	Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)	Ypsomed AG	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2015	1	0

FIG. 1 — Lineage of K122971, 1997–2015Source: 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? (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
*	K102108	Clickfine Pen Needle Summary page 1 …including a 4 mm,;32 gauge needle. 7.6 Substantial Equivalence: The Ypsomed Clickfine Pen Needles are substantially equivalent to the Clickfine Pen Needles (K 102108). The equivalence is supported by the attached documentation. 7.7 Device Description The Ypsomed Clickfine P…	Ypsomed AG	2010	—

Also cleared against K102108: 1 other device →

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
K131125	Clickfine Pen Needle	Ypsomed AG	2013	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 4 companies; a new generation was cleared every 1.9 years on median.
None of the 5 ancestors has a recall.
Of its descendants, K131125 (Ypsomed AG, 2013) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K102108.

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. 2012, 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?

The Clickfine pen needle is intended for the hypodermic injection of fluids into the body when attached to an injection pen.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K122971 · printed Nov 4, 2026

Cite this page

510(k) Report. “K122971: Clickfine Pen Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122971

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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