510(k) · Cleared

Cleared

Artsana Pen Needles, Artsana Injection Needles

K051783510(k) TraditionalCleared Oct 4, 200595-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

Artsana S.P.A · FMI Needle, Hypodermic, Single Lumen

Cleared on Oct 4, 2005 after a 95-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 15 later devices descend from it.

Decided: Oct 4, 2005
Review: 95 days
Class: Class II
Product code: FMI
Recalls: None
Predicates: 0

15 later devices descend from it, 2 citing it directly.

This deviceK051783 Artsana Pen Needles, Artsana Injection NeedlesArtsana S.P.A · 2005
Descendant · cites it directly · 11 of its ownK151311 Safe Block Pen NeedleArtsana S.P.A · 2016
Descendant · 2 generations on · 9 of its ownK161950 Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2017
Descendant · cites it directly · 2 of its ownK110606 MV Intradermic Needles; Magic Needle; Magic NeedleM.V.S.R.L. · 2011
Descendant · 3 generations on · 1 of its ownK210059 Promisemed Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2021
Descendant · 3 generations on · 1 of its ownK193422 Easydrip Pen Needle, Easydrip Plus Pen NeedleSandstone Medical (Suzhou), Inc. · 2021

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2011high 3 (2021) · low 0 (2012)2026

Most influential descendants

Showing 5 of 15 · See all

K151311Safe Block Pen NeedleArtsana S.P.A · 2016 · cites it directly11descendants
K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2017 · 2 generations on9descendants
K110606MV Intradermic Needles; Magic Needle; Magic NeedleM.V.S.R.L. · 2011 · cites it directly2descendants
K210059Promisemed Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2021 · 3 generations on1descendant
K193422Easydrip Pen Needle, Easydrip Plus Pen NeedleSandstone Medical (Suzhou), Inc. · 2021 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K051783	Artsana Pen Needles, Artsana Injection Needles	Artsana S.P.A	2005	—
+1	K151311	Safe Block Pen Needle	Artsana S.P.A	2016	—
+2	K161950	Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle	Promisemed Hangzhou Meditech Co., Ltd.	2017	—
+1	K110606	MV Intradermic Needles; Magic Needle; Magic Needle	M.V.S.R.L.	2011	—
+3	K210059	Promisemed Insulin Pen Needle	Promisemed Hangzhou Meditech Co., Ltd.	2021	—
+3	K193422	Easydrip Pen Needle, Easydrip Plus Pen Needle	Sandstone Medical (Suzhou), Inc.	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2016	1	0
2017	2	0
2019	1	0
2020	2	0
2021	3	0
2023	2	0
2024	1	0
2026	2	0

FIG. 1 — Lineage of K051783, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K151311	Safe Block Pen Needle	Artsana S.P.A	2016	11
K110606	MV Intradermic Needles; Magic Needle; Magic Needle	M.V.S.R.L.	2011	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?

Of its descendants, K151311 (Artsana S.P.A, 2016) has gone furthest, with 11 descendants of its own.

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?

Artsana disposable sterile hypodermic needles are intended for use to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

Artsana disposable sterile pen needles are used with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K051783 · printed Nov 5, 2026

Cite this page

510(k) Report. “K051783: Artsana Pen Needles, Artsana Injection Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051783

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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