510(k) · Cleared

Cleared

Huber Needle Infusion Set Model #20G01 & Y-Site Model #20G01Y

K981683510(k) TraditionalCleared Jul 28, 199876-day reviewClass II21 CFR 880.5440

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

Venusa, Ltd. · FPA Set, Administration, Intravascular

Cleared on Jul 28, 1998 as substantially equivalent to K932638 (Douglas Medical Products Corp., 1993) and 1 other predicate after a 76-day review. Its family tree reaches back 1 generation to 1988.

Decided: Jul 28, 1998
Review: 76 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K884212 (1988). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK884212 Winged Non-Coring Needle SetMarquette Medical, Inc. · 1988
This deviceK981683 Huber Needle Infusion Set Model #20G01 & Y-Site Model #20G01YVenusa, Ltd. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K884212	Winged Non-Coring Needle Set	Marquette Medical, Inc.	1988	—
0 (this device)	K981683	Huber Needle Infusion Set Model #20G01 & Y-Site Model #20G01Y	Venusa, Ltd.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0

FIG. 1 — Lineage of K981683, 1988–1998Source: 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 FPA? 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 FPA device

#1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 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? (3)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K521674	Pfizer Strato Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
*	K932638	Huber Needle Infusion Set Summary page 1 …nufacture these Huber needle infusion sets are substantially equivalent to like products currently legally marketed by Pfizer Strato (KS21674), Douglas Medical Products (K932638), and Marquette Medical (K884212). Venusa, Ltd. Huber Needle Infusion Sets will be packaged in tyvek\mylar pouches or tyvek and p…	Douglas Medical Products Corp.	1993	—
*	K884212	Winged Non-Coring Needle Set Summary page 1 …sion sets are substantially equivalent to like products currently legally marketed by Pfizer Strato (KS21674), Douglas Medical Products (K932638), and Marquette Medical (K884212). Venusa, Ltd. Huber Needle Infusion Sets will be packaged in tyvek\mylar pouches or tyvek and polyethylene form\fil\seal contain…	Marquette Medical, Inc.	1988	—

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.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FPA

11in 2025

2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007high 340 (2023) · low 75 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FPA

98in 2025

2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007high 47,210 (2024) · low 1,499 (2007)2025

MAUDE reports naming product code FPA, 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	16	75	17	1,499
2008	18	89	15	1,941
2009	10	166	166	2,512
2010	23	120	58	2,537
2011	12	87	28	4,407
2012	21	96	16 (4)	4,930
2013	13	90	64	4,651
2014	22	89	24	4,695
2015	17	123	6	6,625
2016	12	195	10	8,470
2017	17	240	13	6,462
2018	4	177	4	6,574
2019	7	161	13	11,227
2020	10	327	107	9,563
2021	13	186	1	10,414
2022	14	213	9 (5)	13,393
2023	14	340	12 (4)	10,916
2024	7	244	13 (1)	47,210
2025	11	225	98 (1)	34,506
2026	5	266	10 (2)	—

What is it indicated for?

The Venusa, Ltd. Huber Needle Infusion Set is intended to be used to deliver solutions and drugs into vascular implant ports.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K981683 · printed Nov 6, 2026

Cite this page

510(k) Report. “K981683: Huber Needle Infusion Set Model #20G01 & Y-Site Model #20G01Y.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981683

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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