510(k) Report

510(k) · Cleared

Cleared

Remove Labeling Restrict From Guide Wires

K912293510(k) TraditionalCleared Dec 5, 1991196-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

Target Therapeutics · DQX Wire, Guide, Catheter

Cleared on Dec 5, 1991 after a 196-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 152 devices in its family, counting itself, has a Class I recall. 151 later devices descend from it.

Decided
Dec 5, 1991
Review
196 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
0

151 later devices descend from it, 1 citing it directly. 1 of the 152 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1997: 1 descendant cleared2002: 6 descendants cleared2000: 3 descendants cleared1999: 1 descendant cleared2004: 3 descendants cleared2001: 1 descendant cleared2003: 3 descendants cleared2006: 1 descendant cleared2010: 7 descendants cleared2009: 10 descendants cleared2007: 5 descendants cleared2008: 8 descendants cleared2005: 3 descendants cleared2011: 9 descendants cleared2013: 11 descendants cleared2017: 6 descendants cleared2012: 11 descendants cleared2014: 7 descendants cleared2015: 8 descendants cleared2020: 3 descendants cleared2016: 7 descendants cleared2018: 5 descendants cleared2022: 7 descendants cleared, 1 with a Class I recall12019: 2 descendants cleared2021: 6 descendants cleared2024: 4 descendants cleared2025: 5 descendants cleared2023: 2 descendants cleared2026: 6 descendants cleared1990200020102020
  1. This deviceK912293 Remove Labeling Restrict From Guide WiresTarget Therapeutics · 1991
  2. Descendant · cites it directly · 150 of its ownK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
  3. Descendant · 2 generations on · 138 of its ownK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
  4. Descendant · 2 generations on · 105 of its ownK993415 GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10…Boston Scientific, Target · 2000
  5. Descendant · 3 generations on · 103 of its ownK022420 Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002
  6. Descendant · 2 generations on · 98 of its ownK993417 GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18…Boston Scientific, Target · 2000

Showing 5 of 151 descendants. See all descendants

Descendants cleared per year

1997: 11999: 12000: 32001: 12002: 62003: 32004: 32005: 32006: 12007: 52008: 82009: 102010: 72011: 92012: 112013: 112014: 72015: 82016: 72017: 62018: 52019: 22020: 32021: 62022: 72023: 22024: 42025: 52026: 6
1997high 11 (2012) · low 0 (1998)2026

Class I recalls in this family

  • K220040 CEREPAK Uniform, Uniform XL, Uniform 3D…7 generations on · 2022

Most influential descendants

Showing 5 of 151 · See all
  • K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…Target Therapeutics · 1997 · cites it directly150descendants
  • K991139Guglielmi Detachable (GDC)Boston Scientific, Target · 1999 · 2 generations on138descendants
  • K993415GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant…Boston Scientific, Target · 2000 · 2 generations on105descendants
  • K022420Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002 · 3 generations on103descendants
  • K993417GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil…Boston Scientific, Target · 2000 · 2 generations on98descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K912293Remove Labeling Restrict From Guide WiresTarget Therapeutics1991—
+1K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein…Target Therapeutics1997—
+2K991139Guglielmi Detachable (GDC)Boston Scientific, Target1999—
+2K993415GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch…Boston Scientific, Target2000—
+3K022420Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp.2002—
+2K993417GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi…Boston Scientific, Target2000—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200030
200110
200260
200330
200430
200530
200610
200750
200880
2009100
201070
201190
2012110
2013110
201470
201580
201670
201760
201850
201920
202030
202160
202271
202320
202440
202550
202660
FIG. 1 — Lineage of K912293, 1991–2026Source: 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), 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. #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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (151)

See all 151

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…Target Therapeutics1997150

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.

  • K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft…Medos International SARL · 2022 · 7 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K971395 (Target Therapeutics, 1997) has gone furthest, with 150 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)—

More from Target Therapeutics

70 FDA decisions under this applicant name. See the company

  • K964488Detachable Silicone Balloon (DSB)Target Therapeutics · 1998
  • K965071Detachable Slicone Balloon (DSB)Target Therapeutics · 1998
  • K964210Retriever IITarget Therapeutics · 1997
  • K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid Coil, Fibered Platinum…Target Therapeutics · 1997
  • K965189SpinnakerTarget Therapeutics · 1997

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/K912293 · printed Nov 4, 2026

Cite this page

510(k) Report. “K912293: Remove Labeling Restrict From Guide Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K912293

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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