510(k) · Cleared

Cleared

Majestik (TM) Shielded Angiography Needle, Model STAN18T71W-25, Majestik (TM) Shielded Angiogtaphy Needle, SRAN18T71WR-5

K022117510(k) TraditionalCleared Oct 11, 2002102-day reviewClass II21 CFR 870.1390

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

Merit Medical Systems, Inc. · DRC Trocar

Cleared on Oct 11, 2002 as substantially equivalent to K011085 (Medamicus, Inc., 2001) and 1 other predicate after a 102-day review. Its family tree reaches back 1 generation to 1995.

Decided: Oct 11, 2002
Review: 102 days
Class: Class II
Product code: DRC
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K951254 (1995). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK951254 Safetyglide NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1995 · Recalled
This deviceK022117 Majestik (TM) Shielded Angiography Needle, Model STAN18T71W-25…Merit Medical Systems, Inc. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K951254	Safetyglide Needle	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995	4
0 (this device)	K022117	Majestik (TM) Shielded Angiography Needle, Model STAN18T71W-25, Majestik (TM)…	Merit Medical Systems, Inc.	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

FIG. 1 — Lineage of K022117, 1995–2002Source: 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 DRC? 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 DRC device

#1 K241042 SafeSharp Transseptal Needle (CLICK071…score 9.2 · 7 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K011085	Guidewire Introducer Safety Needle	Medamicus, Inc.	2001	—
*	K951254	Safetyglide Needle Summary page 1 …edle 21 CFR 880.5570 Classification Panel: General Hospital Regulatory Status: Legally Marketed via K95 1254 Device Description: The Merit Majestik Shielded Angiography Needle is a safety-engineered angiography needle that is used for pr…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995	4
*	—	Majestik Angiography Needle Named without a submission number			—

Also cleared against K011085: 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?

1 of the 2 ancestors has a recall of any class.
3 other devices also cite its predicate K011085.

How does its category compare?

All DRC devices

DRC Trocar: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRC

2in 2024

2007high 2 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRC

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

Recalls per year · DRC

1in 2021

2007high 1 (2009) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DRC

69in 2025

2007high 109 (2023) · low 2 (2008)2025

MAUDE reports naming product code DRC, 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	1	—	0	106
2008	1	—	0	2
2009	0	—	1	17
2010	0	—	1	33
2011	1	—	0	68
2012	1	—	0	58
2013	1	—	1	37
2014	2	—	1	65
2015	0	—	0	52
2016	0	—	0	62
2017	2	—	0	70
2018	2	—	0	85
2019	0	—	1 (1)	95
2020	0	—	0	108
2021	1	—	1	78
2022	2	—	0	61
2023	0	—	0	109
2024	2	—	0	105
2025	0	—	0	69
2026	0	—	0	—

What is it indicated for?

The Merit Majestik Shielded Angiography Needle is used for providing a puncture site in blood vessels for the introduction of vascular access devices. The needle incorporates a safety mechanism to help minimize needlestick injuries after use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022117 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022117: Majestik (TM) Shielded Angiography Needle, Model STAN18T71W-25, Majestik (TM) Shielded Angiogtaphy Needle, SRAN18T71WR-5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022117

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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