510(k) · Cleared

Cleared

Bard Ptfe (Teflon) Coated Guide Wires

K082094510(k) TraditionalCleared Dec 17, 2008146-day reviewClass II21 CFR 870.1330

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

C.R. Bard Inc., Bard Electrophysiology Division · DQX Wire, Guide, Catheter

Cleared on Dec 17, 2008 as substantially equivalent to K772021 (Usci, Div. C.R. Bard, Inc., 1977) and 1 other predicate after a 146-day review. Its family tree reaches back 1 generation to 1977. 1 of the 5 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided: Dec 17, 2008
Review: 146 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K772021 (1977). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK772021 TRC Stainless Steel Safety Spring GuidesUsci, Div. C.R. Bard, Inc. · 1977
This deviceK082094 Bard Ptfe (Teflon) Coated Guide WiresC.R. Bard Inc., Bard Electrophysiology Division · 2008
Descendant · cites it directly · 0 of its ownK160785 Worker GuidewireArgon Medical Devices, Inc. · 2016 · Recalled (Class I)
Descendant · cites it directly · 0 of its ownK120119 Sunmed Guide WireSunny Medical Device (Shenzhen) Co., Ltd. · 2012

Class I recalls in this family

K160785 Worker Guidewirecites it directly · 2016

Most influential descendants

Showing 2 of 2 · See all

K160785Worker GuidewireArgon Medical Devices, Inc. · 2016 · cites it directly0descendants
K120119Sunmed Guide WireSunny Medical Device (Shenzhen) Co., Ltd. · 2012 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K772021	TRC Stainless Steel Safety Spring Guides	Usci, Div. C.R. Bard, Inc.	1977	—
0 (this device)	K082094	Bard Ptfe (Teflon) Coated Guide Wires	C.R. Bard Inc., Bard Electrophysiology Division	2008	—
+1	K160785	Worker Guidewire	Argon Medical Devices, Inc.	2016	Class I
+1	K120119	Sunmed Guide Wire	Sunny Medical Device (Shenzhen) Co., Ltd.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1978	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2016	1	1

FIG. 1 — Lineage of K082094, 1977–2016Source: 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.

1 device in this family has a Class I recall. 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 DQX device

#1 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

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
*	K772021	TRC Stainless Steel Safety Spring Guides Summary page 2 …Predicate Device(s): Bard Preamendment Guide Wires Bard (U.S.C.I.) TRC Stainless Steel Safety Spring Guides K772021 Bard (U.S.C.I.) TRC Teflon Coated Safety Spring Guides K780438 The Bard…	Usci, Div. C.R. Bard, Inc.	1977	—
*	K780438	Safety Spring Guides, Teflon Coated Summary page 2 …teel Safety Spring Guides K772021 Bard (U.S.C.I.) TRC Teflon Coated Safety Spring Guides K780438 The Bard PTFE (Teflon ®) Coated Guide Wires, covered under this 510(k) Premarket Notification are substantially equivalent, in…	C.R. Bard, Inc.	1978	—
*	—	Bard Preamendment Guide Wires Named without a submission number			—

Also cleared against K772021: 1 other device →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K160785	Worker Guidewire Class I	Argon Medical Devices, Inc.	2016	0
K120119	Sunmed Guide Wire	Sunny Medical Device (Shenzhen) Co., Ltd.	2012	0

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K160785Worker GuidewireArgon Medical Devices, Inc. · 2016 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K160785 (Argon Medical Devices, Inc., 2016) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K772021.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · DQX

10in 2025

2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007high 212 (2022) · low 43 (2011)2026

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

Recalls per year · DQX

3in 2024

2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007high 2,210 (2024) · low 687 (2009)2025

MAUDE reports naming product code DQX, 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	14	85	12	760
2008	19	87	7	715
2009	18	87	49	687
2010	21	63	34	987
2011	18	43	3	1,311
2012	20	62	5	1,337
2013	18	119	7 (4)	1,474
2014	18	103	0	1,323
2015	15	112	1	1,323
2016	14	179	2 (2)	1,466
2017	19	85	17	1,524
2018	19	114	9	1,737
2019	13	173	2	1,679
2020	14	106	1 (1)	1,536
2021	6	161	0	1,713
2022	15	212	0	1,647
2023	10	136	0	2,068
2024	11	134	3	2,210
2025	10	177	0	2,178
2026	12	145	4 (1)	—

What is it indicated for?

Bard Guide Wires Indication: Bard PTFE Coated Guide Wires are indicated for percutaneous entry of a guiding catheter into a vessel using standard percutaneous methods (Seldinger's Technique). Generally, Guide Wires which are 100cm or longer are indicated for use with vascular catheters and balloon dilatation catheters in angiographic or interventional procedures. The guide wire may be inserted through an [18g] needle, introducer, or catheter. A guide…

Read the full statement (145 words)

Bard Guide Wires Indication: Bard PTFE Coated Guide Wires are indicated for

percutaneous entry of a guiding catheter into a vessel using standard percutaneous

methods (Seldinger's Technique). Generally, Guide Wires which are 100cm or longer

are indicated for use with vascular catheters and balloon dilatation catheters in

angiographic or interventional procedures. The guide wire may be inserted through an

[18g] needle, introducer, or catheter. A guide wire with an outer diameter of .018" or

smaller may be used with open ended guide wires.

Guide wires which are shorter than 100cm are generally indicated for non-vascular use.

Guide wires with an outer diameter of .018" or smaller may be inserted into the target

organ through a [22g] needle or an open-ended guide wire (60cm or shorter), Larger

guide wires may be inserted through larger gauge needles or an introducer for

placement of dilators and/or drainage catheters.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082094 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082094: Bard Ptfe (Teflon) Coated Guide Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082094

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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