510(k) · Cleared

Cleared

Mini Needle

K151571510(k) TraditionalCleared Oct 14, 2015126-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

Ocujet, LLC · FMI Needle, Hypodermic, Single Lumen

Cleared on Oct 14, 2015 as substantially equivalent to K970370 (Tsk Laboratory, Japan, 1997) after a 126-day review. Its family tree reaches back 1 generation to 1997. 6 later devices descend from it.

Decided: Oct 14, 2015
Review: 126 days
Class: Class II
Product code: FMI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K970370 (1997). 6 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK970370 TSK Sterijekt Premium Disposable Hypodermic NeedleTsk Laboratory, Japan · 1997 · Recalled
This deviceK151571 Mini NeedleOcujet, LLC · 2015
Descendant · cites it directly · 5 of its ownK170768 Mini NeedleOcuject, LLC · 2017
Descendant · 2 generations on · 4 of its ownK183016 SteriCap Mini NeedleOcujet, LLC · 2019
Descendant · 3 generations on · 3 of its ownK212805 SteriCap Mini Needle and Standard NeedlesOcuject, LLC · 2021
Descendant · 4 generations on · 2 of its ownK230959 VitreJect® Needle; OcuSafe® NeedleOcuject, LLC · 2023
Descendant · 4 generations on · 1 of its ownK233343 SteriCap Safety Needle; VitreJect Safety NeedleOcuject, LLC · 2023

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2017high 2 (2023) · low 0 (2018)2026

Most influential descendants

Showing 5 of 6 · See all

K170768Mini NeedleOcuject, LLC · 2017 · cites it directly5descendants
K183016SteriCap Mini NeedleOcujet, LLC · 2019 · 2 generations on4descendants
K212805SteriCap Mini Needle and Standard NeedlesOcuject, LLC · 2021 · 3 generations on3descendants
K230959VitreJect® Needle; OcuSafe® NeedleOcuject, LLC · 2023 · 4 generations on2descendants
K233343SteriCap Safety Needle; VitreJect Safety NeedleOcuject, LLC · 2023 · 4 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970370	TSK Sterijekt Premium Disposable Hypodermic Needle	Tsk Laboratory, Japan	1997	1
0 (this device)	K151571	Mini Needle	Ocujet, LLC	2015	—
+1	K170768	Mini Needle	Ocuject, LLC	2017	—
+2	K183016	SteriCap Mini Needle	Ocujet, LLC	2019	—
+3	K212805	SteriCap Mini Needle and Standard Needles	Ocuject, LLC	2021	—
+4	K230959	VitreJect® Needle; OcuSafe® Needle	Ocuject, LLC	2023	—
+4	K233343	SteriCap Safety Needle; VitreJect Safety Needle	Ocuject, LLC	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0
2019	1	0
2021	1	0
2023	2	0
2024	1	0

FIG. 1 — Lineage of K151571, 1997–2024Source: 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
*	K970370	TSK Sterijekt Premium Disposable Hypodermic Needle Summary page 4 …NAME: DEVICE Class 2, per 21 CFR 880.5570 CLASSIFICATION: PRODUCT CODE FMI PREDICATE DEVICES: (primary) TSK Hypodermic Needle (K970370) Substantially Equivalent To: The Mini Needle is substantially equivalent in intended use, principal of operation and technolo…	Tsk Laboratory, Japan	1997	1

Also cleared against K970370: 2 other devices →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K170768	Mini Needle	Ocuject, LLC	2017	5

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?

Its one ancestor has a recall.
Of its descendants, K170768 (Ocuject, LLC, 2017) has gone furthest, with 5 descendants of its own.
2 other devices also cite its predicate K970370.

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. 2015, 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 Mini Needle is intended for use with a luer-tip syringe (e.g. luer-lock or slip-tip luer syringe) for the administration of drugs

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K151571 · printed Nov 5, 2026

Cite this page

510(k) Report. “K151571: Mini Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K151571

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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