510(k) · Cleared

Cleared

Novofine Autocover 30G X 8MM

K050106510(k) TraditionalCleared Mar 30, 200571-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 Mar 30, 2005 as substantially equivalent to K002403 (Novo Norodisk Pharmaceuticals, Inc., 2000) and 1 other predicate after a 71-day review. Its family tree reaches back 1 generation to 1995. 34 later devices descend from it.

Decided: Mar 30, 2005
Review: 71 days
Class: Class II
Product code: FMI
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K951254 (1995). 2 ancestors in all. 34 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK951254 Safetyglide NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1995 · Recalled
This deviceK050106 Novofine Autocover 30G X 8MMNovo Nordisk, Inc. · 2005
Descendant · cites it directly · 17 of its ownK062500 Flexpen NeedleNovo Nordisk, Inc. · 2006
Descendant · cites it directly · 16 of its ownK090111 Flexpen NeedleNovo Nordisk, Inc. · 2010
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 · 2 generations on · 4 of its ownK113186 Sterile Insulin Pen NeedleShina Corp. · 2012

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2006high 4 (2014) · low 0 (2007)2026

Most influential descendants

Showing 5 of 34 · See all

K062500Flexpen NeedleNovo Nordisk, Inc. · 2006 · cites it directly17descendants
K090111Flexpen NeedleNovo Nordisk, Inc. · 2010 · cites it directly16descendants
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
K113186Sterile Insulin Pen NeedleShina Corp. · 2012 · 2 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K951254	Safetyglide Needle	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995	4
0 (this device)	K050106	Novofine Autocover 30G X 8MM	Novo Nordisk, Inc.	2005	—
+1	K062500	Flexpen Needle	Novo Nordisk, Inc.	2006	—
+1	K090111	Flexpen Needle	Novo Nordisk, Inc.	2010	—
+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	—
+2	K113186	Sterile Insulin Pen Needle	Shina Corp.	2012	—

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
2006	1	0
2010	2	0
2011	2	0
2012	2	0
2014	4	0
2016	2	0
2017	2	0
2018	1	0
2019	1	0
2020	3	0
2021	4	0
2022	2	0
2023	2	0
2024	1	0
2025	2	0
2026	3	0

FIG. 1 — Lineage of K050106, 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? (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
*	K002403	Novofine 31 Disposable Needle Summary page 1 …Class II (3) SUBSTANTIAL EQUIVALENCE: The NovoFine®r AutocoverTm 30G x 8 mm needle is substantially equivalent to the Novo Nordisk NovoFine® 3 ItG x 6 mm needle (K002403) which was cleared by FDA in December 2000 and the Becton Dickenson BD SafetyGlideTm 25G x 16mm needle (K95 1254) which was…	Novo Norodisk Pharmaceuticals, Inc.	2000	—
*	K951254	Safetyglide Needle Summary page 1 …to the Novo Nordisk NovoFine® 3 ItG x 6 mm needle (K002403) which was cleared by FDA in December 2000 and the Becton Dickenson BD SafetyGlideTm 25G x 16mm needle (K95 1254) which was cleared by FDA in October 1995. The term "substantial equivalence" as used in this 5 10(k) notification is limit…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995	4

Also cleared against K002403: 2 other devices →

What descends from it? (34)

See all 34

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

Number	Device	Applicant	Decided	Descendants
K062500	Flexpen Needle	Novo Nordisk, Inc.	2006	17
K090111	Flexpen Needle	Novo Nordisk, Inc.	2010	16
K151311	Safe Block Pen Needle	Artsana S.P.A	2016	11
K093109	Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5')	Novo Nordisk, Inc.	2010	4
K110527	K-Pack Surshield Needle, Hypodermic Needle for Single Use	Terumo Europe N.V.	2011	3

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, K062500 (Novo Nordisk, Inc., 2006) has gone furthest, with 17 descendants of its own.
2 other devices also cite its predicate K002403.

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?

NovoFine® AutocoverTM 30G x 8 mm needles are used in conjunction with insulin injection delivery devices for subcutaneous administration of sterile parenteral insulin products.

Additionally, after withdrawal of the needle from the body, the attached needle safety shield will automatically cover the needle to minimize the risk of accidental needlestick.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050106 · printed Nov 4, 2026

Cite this page

510(k) Report. “K050106: Novofine Autocover 30G X 8MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050106

Report an extraction error

Are you the manufacturer?

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