510(k) · Cleared
ClearedTreasure
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asahi Intecc Co., Ltd. · DQX Wire, Guide, Catheter
Cleared on Oct 5, 2006 as substantially equivalent to K033742 (Boston Scientific Corp, 2004) and 2 other predicates after an 84-day review. Its family tree reaches back 4 generations to 1989. 3 of the 48 devices in its family, counting itself, have a Class I recall. 32 later devices descend from it.
- Decided
- Oct 5, 2006
- Review
- 84 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K890505 (1989). 15 ancestors in all. 32 later devices descend from it, 7 citing it directly. 3 of the 48 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 3 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 2 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 1 generation backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- This deviceK061984 TreasureAsahi Intecc Co., Ltd. · 2006
- Descendant · cites it directly · 27 of its ownK071721 Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371Asahi Intecc Co., Ltd. · 2007
- Descendant · cites it directly · 21 of its ownK103057 Asahi Astato XS 20 Peripheral Guide WireAsahi Intecc Co., Ltd. · 2010
- Descendant · cites it directly · 17 of its ownK083146 Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 &…Asahi Intecc Co., Ltd. · 2008
- Descendant · 2 generations on · 16 of its ownK150445 ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd…Asahi Intecc Co., Ltd. · 2015
- Descendant · 2 generations on · 14 of its ownK153443 ASAHI Astato XS 40Asahi Intecc Co., Ltd. · 2016
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 32 · See all- K071721Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371Asahi Intecc Co., Ltd. · 2007 · cites it directly27descendants
- K103057Asahi Astato XS 20 Peripheral Guide WireAsahi Intecc Co., Ltd. · 2010 · cites it directly21descendants
- K083146Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 & Pagp 1403000Asahi Intecc Co., Ltd. · 2008 · cites it directly17descendants
- K150445ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)Asahi Intecc Co., Ltd. · 2015 · 2 generations on16descendants
- K153443ASAHI Astato XS 40Asahi Intecc Co., Ltd. · 2016 · 2 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −3 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −2 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −1 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| 0 (this device) | K061984 | Treasure | Asahi Intecc Co., Ltd. | 2006 | — |
| +1 | K071721 | Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371 | Asahi Intecc Co., Ltd. | 2007 | — |
| +1 | K103057 | Asahi Astato XS 20 Peripheral Guide Wire | Asahi Intecc Co., Ltd. | 2010 | — |
| +1 | K083146 | Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 & Pagp 1403000 | Asahi Intecc Co., Ltd. | 2008 | — |
| +2 | K150445 | ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) | Asahi Intecc Co., Ltd. | 2015 | — |
| +2 | K153443 | ASAHI Astato XS 40 | Asahi Intecc Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 1 |
| 2021 | 3 | 1 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 1 |
| 2026 | 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.
3 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 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? (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 | Decided |
|---|---|---|---|
| * | K033742 | Boston Scientific V-18 Control Wire Our reading of the summary gave K033724, FDA’s number for Nobel Biocare Centric Post, Models 31234, 31235 and 31236 (Nobel Biocare Uas, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Boston Scientific V-18 guide wire”. | 2004 |
| * | K982876 | HI-Torque Steelcore 18 Guide Wire Model Numbers 1003280, 1003281, 1003282Summary page 1…FR §870.1330 CLASSIFICATION: PRODUCT CODE DQX PREDICATE DEVICE: Boston Scientific V-18 guide wire (K033724) HI-Torque Steelcore 18 guide wire (K982876) JOMED JoWire (K022762) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Asahi Treasure periph… | 1998 |
| * | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002…Summary page 1…DQX PREDICATE DEVICE: Boston Scientific V-18 guide wire (K033724) HI-Torque Steelcore 18 guide wire (K982876) JOMED JoWire (K022762) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Asahi Treasure peripheral guide wire is a steerable guide wire… | 2002 |
What descends from it? (32)
See all 327 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071721 | Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371 | 2007 | 27 |
| K103057 | Asahi Astato XS 20 Peripheral Guide Wire | 2010 | 21 |
| K083146 | Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 & Pagp 1403000 | 2008 | 17 |
| K083145 | Asahi Guide Wire Extension, Model AG149000 | 2009 | 14 |
| K110553 | Asahi Treasure Floppy Peripheral Guide Wire | 2011 | 12 |
| K163426 | ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension | 2017 | 11 |
| K112381 | HI Torque Connect Guidewire | 2011 | 1 |
Has anything in its family been recalled? (3 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.
- K172315Straub Endovascular SystemStraub Medical AG · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 4 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K071721 (Asahi Intecc Co., Ltd., 2007) has gone furthest, with 27 descendants of its own.
- 1 other device also cites its predicate K033742.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 ASAHI Treasure guide wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061984 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061984: Treasure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061984
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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