510(k) · Cleared
ClearedNeowire Pta/Ptca Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neometrics, Inc. · DQX Wire, Guide, Catheter
Cleared on Sep 23, 2010 as substantially equivalent to K070150 (Neometrics, Inc., 2007) and 4 other predicates after a 94-day review. Its family tree reaches back 8 generations to 1989. 1 of the 29 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 23, 2010
- Review
- 94 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K890505 (1989). 28 ancestors in all. No later device cites it as a predicate yet. 1 of the 29 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 7 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 6 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 5 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- 4 generations backK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- 3 generations backK041531 Asahi Ptca Guide Wire Confianza ProAsahi Intecc Co., Ltd. · 2004
- 2 generations backK052339 Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2005
- 1 generation backK082304 Roll-X GuidewireSt Jude Medical · 2008
- This deviceK101729 Neowire Pta/Ptca GuidewireNeometrics, Inc. · 2010
Class I recalls in this family
- K983927 GT1 Floppy, GT1 HI-Per Flex, GT1 Light Supportdirect predicate · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −7 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −6 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −5 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| −4 | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models… | Jomed, Inc. | 2003 | — |
| −3 | K041531 | Asahi Ptca Guide Wire Confianza Pro | Asahi Intecc Co., Ltd. | 2004 | — |
| −2 | K052339 | Asahi Ptca Guide Wire | Asahi Intecc Co., Ltd. | 2005 | — |
| −1 | K082304 | Roll-X Guidewire | St Jude Medical | 2008 | — |
| 0 (this device) | K101729 | Neowire Pta/Ptca Guidewire | Neometrics, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 1 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
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
What was it cleared against? (5)
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 | Decided |
|---|---|---|---|
| * | K070150 | Vascupuncture Picc GuidewireSummary page 1…nformation The following commercially available guidewires are predicate devices for NeoWire. 510(k) Number Trade or Model Name Manufacturer K(070150 VascuPuncture PICC Guidewire Neolvetrics, Inc. K983927 ZingerGuidewire Me… | 2007 |
| * | K983927 | GT1 Floppy, GT1 HI-Per Flex, GT1 Light SupportSummary page 1…evices for NeoWire. 510(k) Number Trade or Model Name Manufacturer K(070150 VascuPuncture PICC Guidewire Neolvetrics, Inc. K983927 ZingerGuidewire Medtronic K(013024 Selectiva Neolvetri… | 1999 |
| * | K013024 | Selectiva GuidewireSummary page 1…Manufacturer K(070150 VascuPuncture PICC Guidewire Neolvetrics, Inc. K983927 ZingerGuidewire Medtronic K(013024 Selectiva Neolvetrics, Inc. K(082304 RolI-X St… | 2001 |
| * | K082304 | Roll-X GuidewireSummary page 1…Neolvetrics, Inc. K983927 ZingerGuidewire Medtronic K(013024 Selectiva Neolvetrics, Inc. K(082304 RolI-X St. Jude Medical K(081337 Approach CTO Coo… | 2008 |
| * | K081337 | Approach Cto Wire GuideSummary page 1…Medtronic K(013024 Selectiva Neolvetrics, Inc. K(082304 RolI-X St. Jude Medical K(081337 Approach CTO Cook 5.4 Device Description NeoWire isa steerable guidewire constructed o… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K983927GT1 Floppy, GT1 HI-Per Flex, GT1 Light SupportArterial Vascular Engineering, Inc. · 1999 · Direct predicate · ◆ in the 1999 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 28 ancestors has a recall of any class; 1 has a Class I recall.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 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?
The N~eoWire Guidewire is Intended to facilitate the Introduction and placement of catheters and interventional devices within the coronary and/or peripheral vasculature. Models with stiff tips I(> 9g) are intended for peripheral use only. Models with Floppy, Soft, and Medium tips (5 9g) are Intended for peripheral or coronary use. The guidewire Isnot Intended for use Inthe cerebral vasculature.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K101729 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101729: Neowire Pta/Ptca Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101729
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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