510(k) Report

510(k) · Cleared

Cleared

TFX Medical Guidewire

K963320510(k) TraditionalCleared Dec 3, 1996102-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

Tfx Medical Group · DQX Wire, Guide, Catheter

Cleared on Dec 3, 1996 as substantially equivalent to K850677 (Teleflexmedical, Inc., 1985) and 19 other predicates after a 102-day review. Its family tree reaches back 1 generation to 1977. 7 of the 124 devices in its family, counting itself, have a Class I recall. 103 later devices descend from it.

Decided
Dec 3, 1996
Review
102 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
22

Its longest line of descent runs back 1 generation to K770977 (1977). 20 ancestors in all. 103 later devices descend from it, 4 citing it directly. 7 of the 124 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1994: 3 other ancestors1993: 1 other ancestor1992: 3 other ancestors1991: 1 other ancestor1990: 4 other ancestors1988: 1 other ancestor1987: 3 other ancestors1986: 1 other ancestor1985: 2 other ancestors2003: 5 descendants cleared2010: 6 descendants cleared2001: 1 descendant cleared2005: 3 descendants cleared2002: 4 descendants cleared2006: 10 descendants cleared2004: 6 descendants cleared2008: 5 descendants cleared2011: 3 descendants cleared2009: 5 descendants cleared2007: 5 descendants cleared2014: 1 descendant cleared2018: 5 descendants cleared, 2 with a Class I recall22020: 3 descendants cleared2019: 5 descendants cleared, 1 with a Class I recall12013: 2 descendants cleared2012: 3 descendants cleared, 1 with a Class I recall12026: 8 descendants cleared2016: 2 descendants cleared2015: 1 descendant cleared2024: 5 descendants cleared, 1 with a Class I recall12025: 7 descendants cleared2023: 3 descendants cleared2021: 3 descendants cleared, 1 with a Class I recall12022: 2 descendants cleared, 1 with a Class I recall1K770977 · Cardiovascular Spring Guides · Lake Region Mfg., Inc. · 1977 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 19 other ancestors 1 generation forward: 4 descendants2 generations forward: 10 descendants3 generations forward: 18 descendants, 1 with a Class I recall14 generations forward: 17 descendants, 1 with a Class I recall15 generations forward: 19 descendants, 1 with a Class I recall16 generations forward: 16 descendants, 1 with a Class I recall17 generations forward: 9 descendants, 1 with a Class I recall18 generations forward: 4 descendants, 2 with a Class I recall29 generations forward: 2 descendants10 generations forward: 3 descendants11 generations forward: 1 descendant K770977 · Cardiovascular Spring Guides · Lake Region Mfg., Inc. · 1977 · recalled0+5+10
  1. Root · 1 generation backK770977 Cardiovascular Spring GuidesLake Region Mfg., Inc. · 1977 · Recalled
  2. This deviceK963320 TFX Medical GuidewireTfx Medical Group · 1996
  3. Descendant · cites it directly · 89 of its ownK012083 Attain Access 6218 Left-Heart Delivery System, Model 6218Medtronic Vascular · 2001
  4. Descendant · 2 generations on · 80 of its ownK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
  5. Descendant · 2 generations on · 37 of its ownK032312 Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular · 2003
  6. Descendant · 3 generations on · 35 of its ownK033989 Medtronic Selectsite Deflectable Catheter System, Models C304-S59…Medtronic Inc. Cardiac Rhythm Management · 2004
  7. Descendant · 2 generations on · 31 of its ownK021587 Attain LDS 6216A Left-Heart Delivery System, Model 6216AMedtronic Vascular · 2002 · Recalled

Showing 5 of 103 descendants. See all descendants

Descendants cleared per year

2001: 12002: 42003: 52004: 62005: 32006: 102007: 52008: 52009: 52010: 62011: 32012: 32013: 22014: 12015: 12016: 22018: 52019: 52020: 32021: 32022: 22023: 32024: 52025: 72026: 8
2001high 10 (2006) · low 0 (2017)2026

Class I recalls in this family

  • K173912 BLUperc Percutaneous Dilation Tracheostomy Kit…3 generations on · 2018
  • K193133 Blue Rhino G1-Multi Percutaneous Tracheostomy…4 generations on · 2019
  • K121611 Amplatzer Torqvue FX5 generations on · 2012
  • K180864 WATCHMAN TruSeal Access System6 generations on · 2018

Most influential descendants

Showing 5 of 103 · See all
  • K012083Attain Access 6218 Left-Heart Delivery System, Model 6218Medtronic Vascular · 2001 · cites it directly89descendants
  • K01351710600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002 · 2 generations on80descendants
  • K032312Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular · 2003 · 2 generations on37descendants
  • K033989Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69Medtronic Inc. Cardiac Rhythm Management · 2004 · 3 generations on35descendants
  • K021587Attain LDS 6216A Left-Heart Delivery System, Model 6216AMedtronic Vascular · 2002 · 2 generations on31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K770977Cardiovascular Spring GuidesLake Region Mfg., Inc.19771
0 (this device)K963320TFX Medical GuidewireTfx Medical Group1996—
+1K012083Attain Access 6218 Left-Heart Delivery System, Model 6218Medtronic Vascular2001—
+2K01351710600 Deflectable Catheter System, Model 10600Medtronic Vascular2002—
+2K032312Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular2003—
+3K033989Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69Medtronic Inc. Cardiac Rhythm Management2004—
+2K021587Attain LDS 6216A Left-Heart Delivery System, Model 6216AMedtronic Vascular20021

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198520
198610
198730
198810
199040
199110
199230
199310
199430

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200240
200350
200460
200530
2006100
200750
200850
200950
201060
201130
201231
201320
201410
201510
201620
201852
201951
202030
202131
202221
202330
202451
202570
202680
FIG. 1 — Lineage of K963320, 1977–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

7 devices in this family have 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. #1 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (22)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K850677Teleflex Guidewire
Summary page 1
…uidewire Common Name Guidewire Classification Name Wire, Guide, Catheter 74 DQX; 21 CFR 870.1330; Class Il medical device 3. Comparison Devices ' Teleflex Guidewire - K850677/B Teleflex Teflon® Coated Guidewire - K860258/A Teleflex Steerable Guidewire - K871850 Arrow International Inc. - K914531, K9246…
Teleflexmedical, Inc.1985—
*K860258Teleflex Teflon Coated Guidewire
Summary page 1
…Name Wire, Guide, Catheter 74 DQX; 21 CFR 870.1330; Class Il medical device 3. Comparison Devices ' Teleflex Guidewire - K850677/B Teleflex Teflon® Coated Guidewire - K860258/A Teleflex Steerable Guidewire - K871850 Arrow International Inc. - K914531, K924607, K924438 Argon Medical Corporation - K841926…
Teleflexmedical, Inc.1986—
*K871850Teleflex Steerable Guidewire
Summary page 1
…R 870.1330; Class Il medical device 3. Comparison Devices ' Teleflex Guidewire - K850677/B Teleflex Teflon® Coated Guidewire - K860258/A Teleflex Steerable Guidewire - K871850 Arrow International Inc. - K914531, K924607, K924438 Argon Medical Corporation - K841926, K871297 Cook Incorporated - K901899, K9…
Teleflexmedical, Inc.1988—
*K914531Stainless Steel Gen Pur Interventional Guide Wires
Summary page 1
…3. Comparison Devices ' Teleflex Guidewire - K850677/B Teleflex Teflon® Coated Guidewire - K860258/A Teleflex Steerable Guidewire - K871850 Arrow International Inc. - K914531, K924607, K924438 Argon Medical Corporation - K841926, K871297 Cook Incorporated - K901899, K920824, K920891 Guidewire Technologi…
Arrow Intl., Inc.19921
*K924607Arrow Fischell Kink Resist Percut Sheath Intro Set
Summary page 1
…arison Devices ' Teleflex Guidewire - K850677/B Teleflex Teflon® Coated Guidewire - K860258/A Teleflex Steerable Guidewire - K871850 Arrow International Inc. - K914531, K924607, K924438 Argon Medical Corporation - K841926, K871297 Cook Incorporated - K901899, K920824, K920891 Guidewire Technologies - K902…
Arrow Intl., Inc.19933
Kept off the family treeK924438Arrow International Inc.
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
Summary page 1
…vices ' Teleflex Guidewire - K850677/B Teleflex Teflon® Coated Guidewire - K860258/A Teleflex Steerable Guidewire - K871850 Arrow International Inc. - K914531, K924607, K924438 Argon Medical Corporation - K841926, K871297 Cook Incorporated - K901899, K920824, K920891 Guidewire Technologies - K902152/3 La…
*K841926Hydroglide Spring Guide Wires
Summary page 1
…/B Teleflex Teflon® Coated Guidewire - K860258/A Teleflex Steerable Guidewire - K871850 Arrow International Inc. - K914531, K924607, K924438 Argon Medical Corporation - K841926, K871297 Cook Incorporated - K901899, K920824, K920891 Guidewire Technologies - K902152/3 Lake Region Manufacturing - K770977, K…
Argon Medical Corp.1985—
*K871297Kadir HI-Torque Guide Wire
Summary page 1
…ex Teflon® Coated Guidewire - K860258/A Teleflex Steerable Guidewire - K871850 Arrow International Inc. - K914531, K924607, K924438 Argon Medical Corporation - K841926, K871297 Cook Incorporated - K901899, K920824, K920891 Guidewire Technologies - K902152/3 Lake Region Manufacturing - K770977, K864058, K…
Argon Medical Corp.1987—
*K901899Roadrunner Wire Guide
Summary page 1
…- K860258/A Teleflex Steerable Guidewire - K871850 Arrow International Inc. - K914531, K924607, K924438 Argon Medical Corporation - K841926, K871297 Cook Incorporated - K901899, K920824, K920891 Guidewire Technologies - K902152/3 Lake Region Manufacturing - K770977, K864058, K871882, K901224, K914138, KS…
Cook, Inc.1990—
*K920824Roadrunner RLTF Guide Wire
Summary page 1
…8/A Teleflex Steerable Guidewire - K871850 Arrow International Inc. - K914531, K924607, K924438 Argon Medical Corporation - K841926, K871297 Cook Incorporated - K901899, K920824, K920891 Guidewire Technologies - K902152/3 Lake Region Manufacturing - K770977, K864058, K871882, K901224, K914138, KS21200, K9…
Cook, Inc.1992—
*K920891Roadrunner (TM) Wire Guide, Modification
Summary page 1
…lex Steerable Guidewire - K871850 Arrow International Inc. - K914531, K924607, K924438 Argon Medical Corporation - K841926, K871297 Cook Incorporated - K901899, K920824, K920891 Guidewire Technologies - K902152/3 Lake Region Manufacturing - K770977, K864058, K871882, K901224, K914138, KS21200, K935170, K9…
Cook, Inc.1992—
*K902152Movable Core Guidewire
Summary page 1
…Arrow International Inc. - K914531, K924607, K924438 Argon Medical Corporation - K841926, K871297 Cook Incorporated - K901899, K920824, K920891 Guidewire Technologies - K902152/3 Lake Region Manufacturing - K770977, K864058, K871882, K901224, K914138, KS21200, K935170, K935198, K941229 Tall Pines Park…
Guidewire Technologies, Inc.1990—
*K902153Teflon Coated GuidewireGuidewire Technologies, Inc.1990—
*K770977Cardiovascular Spring Guides
Summary page 1
…24607, K924438 Argon Medical Corporation - K841926, K871297 Cook Incorporated - K901899, K920824, K920891 Guidewire Technologies - K902152/3 Lake Region Manufacturing - K770977, K864058, K871882, K901224, K914138, KS21200, K935170, K935198, K941229 Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX…
Lake Region Mfg., Inc.19771
*K864058Amplatz Moveable Core Guidewire
Summary page 1
…24438 Argon Medical Corporation - K841926, K871297 Cook Incorporated - K901899, K920824, K920891 Guidewire Technologies - K902152/3 Lake Region Manufacturing - K770977, K864058, K871882, K901224, K914138, KS21200, K935170, K935198, K941229 Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532…
Lake Region Mfg., Inc.1987—
*K871882Lake Region Variable Stiffness Guidewire (VSGW)
Summary page 1
…on Medical Corporation - K841926, K871297 Cook Incorporated - K901899, K920824, K920891 Guidewire Technologies - K902152/3 Lake Region Manufacturing - K770977, K864058, K871882, K901224, K914138, KS21200, K935170, K935198, K941229 Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or…
Lake Region Mfg., Inc.1987—
*K901224Insite Steerable Guidewire
Summary page 1
…l Corporation - K841926, K871297 Cook Incorporated - K901899, K920824, K920891 Guidewire Technologies - K902152/3 Lake Region Manufacturing - K770977, K864058, K871882, K901224, K914138, KS21200, K935170, K935198, K941229 Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108 A a…
Lake Region Mfg., Inc.1990—
*K914138Ontrac
Summary page 1
…tion - K841926, K871297 Cook Incorporated - K901899, K920824, K920891 Guidewire Technologies - K902152/3 Lake Region Manufacturing - K770977, K864058, K871882, K901224, K914138, KS21200, K935170, K935198, K941229 Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108 A a e ae e a…
Lake Region Mfg., Inc.1991—
Kept off the family treeK521200Lake Region Manufacturing
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
*K935170Cardiovascular and Vascular Guidewire Modifications
Summary page 1
…71297 Cook Incorporated - K901899, K920824, K920891 Guidewire Technologies - K902152/3 Lake Region Manufacturing - K770977, K864058, K871882, K901224, K914138, KS21200, K935170, K935198, K941229 Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108 A a e ae e a D…
Lake Region Mfg., Inc.1994—
*K935198Gastroenterology and Urology Guidewire Modifications
Summary page 1
…k Incorporated - K901899, K920824, K920891 Guidewire Technologies - K902152/3 Lake Region Manufacturing - K770977, K864058, K871882, K901224, K914138, KS21200, K935170, K935198, K941229 Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108 A a e ae e a Descriptio…
Lake Region Mfg., Inc.1994—
*K941229Ontrac Steerable Guidewire
Summary page 1
…rated - K901899, K920824, K920891 Guidewire Technologies - K902152/3 Lake Region Manufacturing - K770977, K864058, K871882, K901224, K914138, KS21200, K935170, K935198, K941229 Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108 A a e ae e a Description of Devi…
Lake Region Mfg., Inc.1994—

What descends from it? (103)

See all 103

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

NumberDeviceApplicantDecidedDescendants
K012083Attain Access 6218 Left-Heart Delivery System, Model 6218Medtronic Vascular200189
K022212Portex Percutaneous Dilatational Tracheostomy KitsMentor Medical Limited200310
K094062Percu-Pro GuidewireCardiosolutions, Inc.20100
K043446Emmebi Central Venous Catheter Kit with Lestep Safety IntroducerEmmebi Srl20050

Has anything in its family been recalled? (7 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.

  • K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation…Smiths Medical Asd, Inc. · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
  • K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy…Cook Incorporated · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
  • K121611Amplatzer Torqvue FXAga Medical Corporation · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
  • K180864WATCHMAN TruSeal Access SystemBoston Scientific · 2018 · 6 generations on · ◆ in the 2018 descendants bar of FIG. 15 Class I recalls
  • K212228WATCHMAN FXD Curve Access SystemBoston Scientific Corporation · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 13 Class I recalls
  • K220340Amplatzer Steerable Delivery SheathAbbott Medical · 2022 · 8 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
  • K240018WATCHMAN TruSteer Access System (M635TU90050)Boston Scientific Corporation · 2024 · 8 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall

Nearest 5 of 7; all are on the web page.

What does this lineage say?

  • 3 of the 20 ancestors have a recall of any class.
  • Of its descendants, K012083 (Medtronic Vascular, 2001) has gone furthest, with 89 descendants of its own.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQX

10in 2025

2007: 142008: 192009: 182010: 212011: 182012: 202013: 182014: 182015: 152016: 142017: 192018: 192019: 132020: 142021: 62022: 152023: 102024: 112025: 102026 (partial year): 12
2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007: 85 days median2008: 87 days median2009: 87 days median2010: 63 days median2011: 43 days median2012: 62 days median2013: 119 days median2014: 103 days median2015: 112 days median2016: 179 days median2017: 85 days median2018: 114 days median2019: 173 days median2020: 106 days median2021: 161 days median2022: 212 days median2023: 136 days median2024: 134 days median2025: 177 days median2026 (partial year): 145 days median
2007high 212 (2022) · low 43 (2011)2026

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

Recalls per year · DQX

3in 2024

2007: 122008: 72009: 492010: 342011: 32012: 52013: 7, 4 Class I2015: 12016: 2, 2 Class I2017: 172018: 92019: 22020: 1, 1 Class I2024: 32026 (partial year): 4, 1 Class I
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

2007: 7602008: 7152009: 6872010: 9872011: 1,3112012: 1,3372013: 1,4742014: 1,3232015: 1,3232016: 1,4662017: 1,5242018: 1,7372019: 1,6792020: 1,5362021: 1,7132022: 1,6472023: 2,0682024: 2,2102025: 2,178
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007148512760
200819877715
2009188749687
2010216334987
2011184331,311
2012206251,337
2013181197 (4)1,474
20141810301,323
20151511211,323
2016141792 (2)1,466
20171985171,524
20181911491,737
20191317321,679
2020141061 (1)1,536
2021616101,713
20221521201,647
20231013602,068
20241113432,210
20251017702,178
2026121454 (1)—

What is it indicated for?

TFX Medical Guidewires are intended to fit inside a percutaneous catheter for the purpose of directing it through a blood vessel or other natural channel - excluding use in coronary arteries and in the neurovasculature.

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

More from Tfx Medical Group

3 FDA decisions under this applicant name. See the company

  • K992664TFX Medical Stylet CatheterTfx Medical Group · 2000
  • K991647TFX Medical Introducer KitTfx Medical Group · 2000

Recent decisions in DQX

The DQX category page

  • K260168Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)Skycade Med Corporation · 2026
  • K253146Hyperdrive 35 GuidewireRapid-Medical, Ltd. · 2026
  • K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd. · 2026
  • K253667Accoat Guide WireSp Medical A/S · 2026
  • K261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland, Ltd. · 2026

https://510kreport.com/device/K963320 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963320: TFX Medical Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963320

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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