510(k) · Cleared
ClearedInQwire Amplatz Guide Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Ireland, Ltd. · DQX Wire, Guide, Catheter
Cleared on May 22, 2026 as substantially equivalent to K163575 (Merit Medical Systems, Inc., 2017) and 1 other predicate after a 151-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- May 22, 2026
- Review
- 151 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K002289 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK002289 Inqwire Diagnostic Guide WireMerit Medical Systems, Inc. · 2000
- 3 generations backK133230 Inqwire Diagnostic Guide WireMerit Medical Systems, Inc. · 2013
- 2 generations backK163575 Inqwire Diagnostic Guide WireMerit Medical Systems, Inc. · 2017
- 1 generation backK170700 Inqwire Diagnostic Guide WireMerit Medical Systems, Inc. · 2017
- This deviceK254137 InQwire Amplatz Guide WireMerit Medical Ireland, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002289 | Inqwire Diagnostic Guide Wire | Merit Medical Systems, Inc. | 2000 | — |
| −3 | K133230 | Inqwire Diagnostic Guide Wire | Merit Medical Systems, Inc. | 2013 | — |
| −2 | K163575 | Inqwire Diagnostic Guide Wire | Merit Medical Systems, Inc. | 2017 | — |
| −1 | K170700 | Inqwire Diagnostic Guide Wire | Merit Medical Systems, Inc. | 2017 | — |
| 0 (this device) | K254137 | InQwire Amplatz Guide Wire | Merit Medical Ireland, Ltd. | 2026 | — |
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 |
|---|---|---|---|
| * | K163575 | Inqwire Diagnostic Guide WireSummary page 6…Regulation Number: 21 CFR 870.1330 Regulation Medical Specialty Cardiovascular Premarket Notification: K163575 & K170700 Predicate Manufacturer: Merit Medical Systems Inc. Device Mer… | 2017 |
| * | K170700 | Inqwire Diagnostic Guide WireSummary page 6…Regulation Number: 21 CFR 870.1330 Regulation Medical Specialty Cardiovascular Premarket Notification: K163575 & K170700 Predicate Manufacturer: Merit Medical Systems Inc. Device Merit’s InQwi… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 2 companies; a new generation was cleared every 9.1 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K163575.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254137 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254137: InQwire Amplatz Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254137
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026