510(k) · Cleared

Cleared

Ultracare Disposable Pen Needles, Models 31 Gauge X3/16, 29 Gauge X 1/2

K050464510(k) TraditionalCleared May 11, 200577-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

Ultimed, Inc. · FMI Needle, Hypodermic, Single Lumen

Cleared on May 11, 2005 as substantially equivalent to K002938 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 2000) and 1 other predicate after a 77-day review. Its family tree reaches back 1 generation to 2000.

Decided: May 11, 2005
Review: 77 days
Class: Class II
Product code: FMI
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K002938 (2000). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK002938 B-D Ultra-Fine Iii Pen Needle; Model 31G X 3/16Bd Becton Dickinson Vacutainer Systems Preanalytic · 2000
This deviceK050464 Ultracare Disposable Pen Needles, Models 31 Gauge X3/16, 29 Gauge X…Ultimed, Inc. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002938	B-D Ultra-Fine Iii Pen Needle; Model 31G X 3/16	Bd Becton Dickinson Vacutainer Systems Preanalytic	2000	—
0 (this device)	K050464	Ultracare Disposable Pen Needles, Models 31 Gauge X3/16, 29 Gauge X 1/2	Ultimed, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K050464, 2000–2005Source: 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
*	K002938	B-D Ultra-Fine Iii Pen Needle; Model 31G X 3/16 Summary page 1 …bstantially equivalent in intended use, fuinction and basic composition to the currently marketed Becton Dickinson B-D Ultra-Fine III Pen Needle; Model 31 gauge x 3/16", K002938, and to the Becton Dickinson B-D Ultra-Fine Original Pen Needle (29 gauge x 1/2"), K03 1200. Device Description The UltiCare Disp…	Bd Becton Dickinson Vacutainer Systems Preanalytic	2000	—
*	K031200	Modification to BD Ultra-Fine Iii Pen Needle Summary page 1 …rketed Becton Dickinson B-D Ultra-Fine III Pen Needle; Model 31 gauge x 3/16", K002938, and to the Becton Dickinson B-D Ultra-Fine Original Pen Needle (29 gauge x 1/2"), K03 1200. Device Description The UltiCare Disposable Pen Needles are sterile, single-use, type A, hypodermic single lumen needles designed…	Becton, Dickinson & CO	2003	—

Also cleared against K002938: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

None of the 2 ancestors has a recall.
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 UltiCare disposable 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 summary.

https://510kreport.com/device/K050464 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050464: Ultracare Disposable Pen Needles, Models 31 Gauge X3/16, 29 Gauge X 1/2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050464

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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