510(k) · Cleared

Recalled · 2007

BD Autoshield Pen Needle

K060007510(k) TraditionalCleared Mar 23, 200679-day reviewClass II21 CFR 880.5570Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Becton, Dickinson & CO · FMI Needle, Hypodermic, Single Lumen

Cleared on Mar 23, 2006 as substantially equivalent to K051899 (Becton, Dickinson & CO, 2005) after a 79-day review. Its family tree reaches back 1 generation to 2005. 18 later devices descend from it. It has been recalled once.

Decided: Mar 23, 2006
Review: 79 days
Class: Class II
Product code: FMI
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K051899 (2005). 18 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK051899 BD Pen NeedleBecton, Dickinson & CO · 2005
This deviceK060007 BD Autoshield Pen NeedleBecton, Dickinson & CO · 2006
Descendant · cites it directly · 8 of its ownK131123 Clickfine Autoprotect Pen NeedleYpsomed AG · 2013
Descendant · 2 generations on · 7 of its ownK152514 Clickfine AutoProtect Pen NeedleYpsomed AG · 2015
Descendant · 3 generations on · 4 of its ownK181447 Safety insulin needle for single useBerpu Medical Technology Co., Ltd. · 2019
Descendant · cites it directly · 4 of its ownK163578 EasyTouch Safety Pen NeedleMhc Medical Products, LLC · 2018
Descendant · 2 generations on · 3 of its ownK220129 Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2022

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2011high 6 (2022) · low 0 (2012)2026

Most influential descendants

Showing 5 of 18 · See all

K131123Clickfine Autoprotect Pen NeedleYpsomed AG · 2013 · cites it directly8descendants
K152514Clickfine AutoProtect Pen NeedleYpsomed AG · 2015 · 2 generations on7descendants
K181447Safety insulin needle for single useBerpu Medical Technology Co., Ltd. · 2019 · 3 generations on4descendants
K163578EasyTouch Safety Pen NeedleMhc Medical Products, LLC · 2018 · cites it directly4descendants
K220129Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2022 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K051899	BD Pen Needle	Becton, Dickinson & CO	2005	—
0 (this device)	K060007	BD Autoshield Pen Needle	Becton, Dickinson & CO	2006	—
+1	K131123	Clickfine Autoprotect Pen Needle	Ypsomed AG	2013	—
+2	K152514	Clickfine AutoProtect Pen Needle	Ypsomed AG	2015	—
+3	K181447	Safety insulin needle for single use	Berpu Medical Technology Co., Ltd.	2019	—
+1	K163578	EasyTouch Safety Pen Needle	Mhc Medical Products, LLC	2018	—
+2	K220129	Promisemed X-Safety Pen Needle	Promisemed Hangzhou Meditech Co., Ltd.	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2013	1	0
2015	1	0
2016	1	0
2018	1	0
2019	1	0
2020	1	0
2022	6	0
2026	5	0

FIG. 1 — Lineage of K060007, 2005–2026Source: 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? (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
*	K051899	BD Pen Needle Our reading of the summary gave K051889, FDA’s number for Carevent CA and Dra (O-Two Medical Technologies, Inc.). Corrected to the number one digit away that FDA lists under the company the summary names beside it.	Becton, Dickinson & CO	2005	—

Also cleared against K051899: 13 other devices →

What descends from it? (18)

See all 18

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

Number	Device	Applicant	Decided	Descendants
K131123	Clickfine Autoprotect Pen Needle	Ypsomed AG	2013	8
K163578	EasyTouch Safety Pen Needle	Mhc Medical Products, LLC	2018	4
K110703	BD Autoshield Duo Pen Needle	Becton, Dickinson and Company	2011	2
K161553	BD SafeAssist	Becton, Dickinson and Company	2016	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 23, 2007	Not classified	Z-0838-2007	Other	Needle Sticks: Complaints were received regarding Needle Stick Injuries while administering insulin to patients. (Labeling will be revised to provide clear direction on product usage)

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K131123 (Ypsomed AG, 2013) has gone furthest, with 8 descendants of its own.
13 other devices also cite its predicate K051899.

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 BD AutoShieldTM Pen Needle is intended for use with pen injector devices for the injection of drugs, including insulin and exinatide.

Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060007 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060007: BD Autoshield 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/K060007

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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