510(k) · Cleared

Recalled · Class II · 2021

Unifine Pentips/ Unifine Pentips Plus

K152339510(k) TraditionalCleared Jun 24, 2016310-day reviewClass II21 CFR 880.5570Recalls 3

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

Owen Mumford, Ltd. · FMI Needle, Hypodermic, Single Lumen

Cleared on Jun 24, 2016 as substantially equivalent to K973899 (Owen Mumford USA, Inc., 1997) after a 310-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it. It has been recalled 3 times.

Decided: Jun 24, 2016
Review: 310 days
Class: Class II
Product code: FMI
Recalls: 3
Predicates: 1

Its longest line of descent runs back 1 generation to K973899 (1997). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK973899 Unifine PentipsOwen Mumford USA, Inc. · 1997
This deviceK152339 Unifine Pentips/ Unifine Pentips PlusOwen Mumford, Ltd. · 2016
Descendant · cites it directly · 1 of its ownK173881 Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30GOwen Mumford, Ltd. · 2018
Descendant · 2 generations on · 0 of its ownK210399 Unifine SafeControlOwen Mumford, Ltd. · 2021

Most influential descendants

Showing 2 of 2 · See all

K173881Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30GOwen Mumford, Ltd. · 2018 · cites it directly1descendant
K210399Unifine SafeControlOwen Mumford, Ltd. · 2021 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K973899	Unifine Pentips	Owen Mumford USA, Inc.	1997	—
0 (this device)	K152339	Unifine Pentips/ Unifine Pentips Plus	Owen Mumford, Ltd.	2016	—
+1	K173881	Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G	Owen Mumford, Ltd.	2018	—
+2	K210399	Unifine SafeControl	Owen Mumford, Ltd.	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0
2021	1	0

FIG. 1 — Lineage of K152339, 1997–2021Source: 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
*	K973899	Unifine Pentips Summary page 4 …70) Regulatory Class: II Product Code: FMI 3. Predicate Devices ® ® Primary Predicate Device 1 Name: Unifine Pentips , K973899 ® Reference Predicate Device 2 Name: Artsana InsuPen Insulin Pen Needles,…	Owen Mumford USA, Inc.	1997	—
†	K051783	Artsana Pen Needles, Artsana Injection Needles	Artsana S.P.A	2005	—
†	K051899	BD Pen Needle	Becton, Dickinson & CO	2005	—
†	K100005	BD Pen Needle	Becton, Dickinson and Co.	2010	—

Also cleared against K973899: 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
K173881	Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G	Owen Mumford, Ltd.	2018	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 26, 2021	Class II	Z-2078-2021	Package design/selection	Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of Unifine Pentips Plus 8mm pen needles.
Nov 6, 2017	Class II	Z-0382-2018	Environmental control	Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.
Nov 6, 2017	Class II	Z-0381-2018	Environmental control	Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K173881 (Owen Mumford, Ltd., 2018) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K973899.

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. 2016, 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 Unifine Pentips range of pen needles are intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K152339 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152339: Unifine Pentips/ Unifine Pentips Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152339

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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