510(k) · Cleared

Cleared

Nipro Huber Infusion, Excel Huber Needle

K113469510(k) TraditionalCleared Oct 18, 2012331-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

Nipro Medical Corporation · FMI Needle, Hypodermic, Single Lumen

Cleared on Oct 18, 2012 as substantially equivalent to K895769 (Exel Intl., 1990) after a 331-day review. Its family tree reaches back 1 generation to 1990.

Decided: Oct 18, 2012
Review: 331 days
Class: Class II
Product code: FMI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K895769 (1990). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK895769 Exel Huber NeedleExel Intl. · 1990 · Recalled
This deviceK113469 Nipro Huber Infusion, Excel Huber NeedleNipro Medical Corporation · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K895769	Exel Huber Needle	Exel Intl.	1990	1
0 (this device)	K113469	Nipro Huber Infusion, Excel Huber Needle	Nipro Medical Corporation	2012	—

FIG. 1 — Lineage of K113469, 1990–2012Source: 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
*	K895769	Exel Huber Needle Summary page 1 …Lumen Classification Code: FMI (per 21 CFR 880.5570) Class 11 3. Predicate Device: EXEL Huber Needle (K895769) 4. Device Description: This device consists of a cannula affixed to a hub with a needle cap. Both straight and 90 angled…	Exel Intl.	1990	1

Also cleared against K895769: 1 other device →

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?

Its one ancestor has a recall.
1 other device also cites its predicate K895769.

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. 2012, 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?

This device is intended for administration of drug solutions, or blood sampling into or from a

Reservoir implanted in the body.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113469 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113469: Nipro Huber Infusion, Excel Huber Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113469

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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