510(k) · Cleared

Cleared

Manan Gwi Guide Wire Introducer

K851834510(k) TraditionalCleared Jul 11, 198576-day reviewClass I21 CFR 870.4500

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

Manan Manufacturing Co., Inc. · DWS Instruments, Surgical, Cardiovascular

Cleared on Jul 11, 1985 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided: Jul 11, 1985
Review: 76 days
Class: Class I
Product code: DWS
Recalls: None
Predicates: 0

6 later devices descend from it, 3 citing it directly.

This deviceK851834 Manan Gwi Guide Wire IntroducerManan Manufacturing Co., Inc. · 1985
Descendant · cites it directly · 1 of its ownK130730 V-Stick Vascular Access SetArgon Medical · 2013
Descendant · cites it directly · 1 of its ownK040029 Safetynet Guidewire IntroducerInjectimed, Inc. · 2004
Descendant · cites it directly · 1 of its ownK974745 Manan Gwi Guide Wire IntroducerMedical Device Technologies, Inc. · 1998 · Recalled
Descendant · 2 generations on · 0 of its ownK253741 V•Stick™ Vascular Access SetArgon Medical Devices, Inc. · 2025
Descendant · 2 generations on · 0 of its ownK073664 Frontline Medical Safetynet Guidewire IntroducerInjectimed, Inc. · 2008

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1998high 1 (1998) · low 0 (1999)2026

Most influential descendants

Showing 5 of 6 · See all

K130730V-Stick Vascular Access SetArgon Medical · 2013 · cites it directly1descendant
K040029Safetynet Guidewire IntroducerInjectimed, Inc. · 2004 · cites it directly1descendant
K974745Manan Gwi Guide Wire IntroducerMedical Device Technologies, Inc. · 1998 · cites it directly1descendant
K253741V•Stick™ Vascular Access SetArgon Medical Devices, Inc. · 2025 · 2 generations on0descendants
K073664Frontline Medical Safetynet Guidewire IntroducerInjectimed, Inc. · 2008 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K851834	Manan Gwi Guide Wire Introducer	Manan Manufacturing Co., Inc.	1985	—
+1	K130730	V-Stick Vascular Access Set	Argon Medical	2013	—
+1	K040029	Safetynet Guidewire Introducer	Injectimed, Inc.	2004	—
+1	K974745	Manan Gwi Guide Wire Introducer	Medical Device Technologies, Inc.	1998	1
+2	K253741	V•Stick™ Vascular Access Set	Argon Medical Devices, Inc.	2025	—
+2	K073664	Frontline Medical Safetynet Guidewire Introducer	Injectimed, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2002	1	0
2004	1	0
2008	1	0
2013	1	0
2025	1	0

FIG. 1 — Lineage of K851834, 1985–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DWS? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K130730	V-Stick Vascular Access Set	Argon Medical	2013	1
K040029	Safetynet Guidewire Introducer	Injectimed, Inc.	2004	1
K974745	Manan Gwi Guide Wire Introducer	Medical Device Technologies, Inc.	1998	1

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?

Of its descendants, K130730 (Argon Medical, 2013) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DWS devices

DWS Instruments, Surgical, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWS

FDA has decided no DWS device since 2007.

Median 510(k) review, days · DWS

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

Recalls per year · DWS

1in 2022

2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DWS

12in 2025

2007high 60 (2018) · low 12 (2025)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	20
2008	—	0	15
2009	—	0	44
2010	—	1	27
2011	—	1	55
2012	—	0	33
2013	—	0	34
2014	—	0	43
2015	—	0	26
2016	—	1	33
2017	—	0	40
2018	—	0	60
2019	—	0	28
2020	—	0	28
2021	—	0	32
2022	—	1	35
2023	—	0	18
2024	—	0	48
2025	—	0	12
2026	—	0	—

https://510kreport.com/device/K851834 · printed Nov 5, 2026

Cite this page

510(k) Report. “K851834: Manan Gwi Guide Wire Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K851834

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026