510(k) · Cleared

Cleared

Vwing Vascular Needle Guide, 4MM X 07MM; Vwing Vascular Needle Guide, 6MM X 07MM; Vwing Vascular Needle Guide, 8MM X 07M

K130873510(k) TraditionalCleared Sep 13, 2013168-day reviewClass II21 CFR 876.5540

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

Vital Access · PFH Venous Window Needle Guide

Cleared on Sep 13, 2013 as substantially equivalent to K990803 (Medisystems Corp., 2000) and 1 other predicate after a 168-day review. Its family tree reaches back 2 generations to 1983.

Decided: Sep 13, 2013
Review: 168 days
Class: Class II
Product code: PFH
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K823068 (1983). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK823068 Medisystems Fistula NeedlesMedisystems Corp. · 1983
1 generation backK990803 Medisystems Buttonhole Needle SetsMedisystems Corp. · 2000 · Recalled
This deviceK130873 Vwing Vascular Needle Guide, 4MM X 07MM; Vwing Vascular Needle…Vital Access · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K823068	Medisystems Fistula Needles	Medisystems Corp.	1983	—
−1	K990803	Medisystems Buttonhole Needle Sets	Medisystems Corp.	2000	1
0 (this device)	K130873	Vwing Vascular Needle Guide, 4MM X 07MM; Vwing Vascular Needle Guide, 6MM X…	Vital Access	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	2	0

FIG. 1 — Lineage of K130873, 1983–2013Source: 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 PFH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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
*	K990803	Medisystems Buttonhole Needle Sets Summary page 1 …theter Classification Reference: 21 CFR § 876.5540 Proposed Regulatory Class: Class 11 Proposed Product Code: Predicate 1)evices: K990803 - Medisystemns Corp. Medisystems Buttonhole Needle Sets K…	Medisystems Corp.	2000	1
*	K926139	Cathlink 20 Titanium Port W/Att. Polyurethane Cath Summary page 1 …edicate 1)evices: K990803 - Medisystemns Corp. Medisystems Buttonhole Needle Sets K926139 - BARD Access Systems. Inc. Cathlink 20 Titanium Port wv/ Att. Polyurethane Cath IDevice D…	Bard Access Systems, Inc.	1995	—

Also cleared against K990803: 3 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?

The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 16.9 years on median.
2 of the 4 ancestors have a recall of any class.
3 other devices also cite its predicate K990803.

How does its category compare?

All PFH devices

PFH Venous Window Needle Guide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · PFH

1in 2013

2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PFH

Too few PFH 510(k)s in any year since 2007 to give a median.

Recalls per year · PFH

No recall names PFH since 2007.

Adverse event reports per year · PFH

2in 2017

2007high 7 (2016) · low 0 (2007)2025

MAUDE reports naming product code PFH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	1	—	1
2014	0	—	5
2015	0	—	0
2016	0	—	7
2017	0	—	2
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The VWING Vascular Needle Guide is indicated for use as an access device accessory on arteriovenous fistulas (AVF) for hemodialysis procedures using a constant site or "buttonhole" method of needle insertion.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K130873 · printed Nov 5, 2026

Cite this page

510(k) Report. “K130873: Vwing Vascular Needle Guide, 4MM X 07MM; Vwing Vascular Needle Guide, 6MM X 07MM; Vwing Vascular Needle Guide, 8MM X 07M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130873

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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