510(k) · Cleared
ClearedAsahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 & Pagp 1403000
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 Nov 21, 2008 as substantially equivalent to K052022 (Asahi Intecc Co., Ltd., 2005) and 1 other predicate after a 29-day review. Its family tree reaches back 6 generations to 1989. 17 later devices descend from it.
- Decided
- Nov 21, 2008
- Review
- 29 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K890505 (1989). 18 ancestors in all. 17 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 5 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 4 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 3 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- 2 generations backK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- 1 generation backK052022 Asahi Ptca Guide Wire FielderAsahi Intecc Co., Ltd. · 2005
- This deviceK083146 Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 &…Asahi Intecc Co., Ltd. · 2008
- Descendant · cites it directly · 16 of its ownK150445 ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd…Asahi Intecc Co., Ltd. · 2015
- Descendant · cites it directly · 11 of its ownK163426 ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide…Asahi Intecc Co., Ltd. · 2017
- Descendant · 2 generations on · 3 of its ownK203533 Vassallo GTFilmecc Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK213868 ASAHI Gladius Mongo18 PV ESAsahi Intecc Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK212268 FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension…FMD Co., Ltd. · 2022
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K150445ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)Asahi Intecc Co., Ltd. · 2015 · cites it directly16descendants
- K163426ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire ExtensionAsahi Intecc Co., Ltd. · 2017 · cites it directly11descendants
- K203533Vassallo GTFilmecc Co., Ltd. · 2021 · 2 generations on3descendants
- K213868ASAHI Gladius Mongo18 PV ESAsahi Intecc Co., Ltd. · 2022 · 2 generations on1descendant
- K212268FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXTFMD Co., Ltd. · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −5 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −4 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −3 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| −2 | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models… | Jomed, Inc. | 2003 | — |
| −1 | K052022 | Asahi Ptca Guide Wire Fielder | Asahi Intecc Co., Ltd. | 2005 | — |
| 0 (this device) | K083146 | Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 & Pagp 1403000 | Asahi Intecc Co., Ltd. | 2008 | — |
| +1 | K150445 | ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) | Asahi Intecc Co., Ltd. | 2015 | — |
| +1 | K163426 | ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire… | Asahi Intecc Co., Ltd. | 2017 | — |
| +2 | K203533 | Vassallo GT | Filmecc Co., Ltd. | 2021 | — |
| +2 | K213868 | ASAHI Gladius Mongo18 PV ES | Asahi Intecc Co., Ltd. | 2022 | — |
| +2 | K212268 | FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT | FMD Co., Ltd. | 2022 | — |
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 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 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.
Planning a device in DQX? 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? (2)
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 |
|---|---|---|---|
| * | K052022 | Asahi Ptca Guide Wire FielderSummary page 1…Wire, Guide, Catheter DEVICE Class 2 per 21 CER §870.1330 CLASSIFICATION: PRODUCT CODE DQX PREDICATE DEVICE: Asahi PTCA Guide Wire Fielder - K052022 Asahi Treasure Guide Wire - K061984 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The As… | 2005 |
| * | K061984 | TreasureSummary page 1…1 CER §870.1330 CLASSIFICATION: PRODUCT CODE DQX PREDICATE DEVICE: Asahi PTCA Guide Wire Fielder - K052022 Asahi Treasure Guide Wire - K061984 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Asahi Regalia XS 1.0 Peripheral Guide Wire is steerable guid… | 2006 |
What descends from it? (17)
See all 173 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K150445 (Asahi Intecc Co., Ltd., 2015) has gone furthest, with 16 descendants of its own.
- 7 other devices also cite its predicate K052022.
How does its category compare?
All DQX devicesDQX 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
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 Regalia XS 1.0 Peripheral 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/K083146 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083146: Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 & Pagp 1403000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083146
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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