510(k) · Cleared
ClearedBard Hydrophilic Coated Guide Wires
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · DQX Wire, Guide, Catheter
Cleared on Nov 2, 1999 as substantially equivalent to K974713 (C.R. Bard, Inc., 1998) after a 56-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Nov 2, 1999
- Review
- 56 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974713 (1998). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K120119Sunmed Guide WireSunny Medical Device (Shenzhen) Co., Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974713 | Bard Hydrophillic Coated Guide Wire | C.R. Bard, Inc. | 1998 | — |
| 0 (this device) | K993000 | Bard Hydrophilic Coated Guide Wires | C.R. Bard, Inc. | 1999 | — |
| +1 | K120119 | Sunmed Guide Wire | Sunny Medical Device (Shenzhen) Co., Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (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 |
|---|---|---|---|
| * | K974713 | Bard Hydrophillic Coated Guide WireSummary page 2…Technological Characteristics Summary: The Bard Hydrophilic Coated Guide Wire discussed in this 510(k) is similar the Bard Hydrophilic Coated Guide Wires discussed in K974713 which were similar to the Terumo Glidewire regarding materials and construction, and is similar to Bard Silk Guide Wires, Bard An… | 1998 |
| * | — | Bard Preamendment Angiographic Guide Wires Named without a submission number | |
| * | — | Bard PTCA Steerable Standard Guide Wire Named without a submission number | |
| * | — | Bard Silk Guide Wire Named without a submission number | |
| * | — | Terumo Glidewire Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120119 | Sunmed Guide Wire | 2012 | 0 |
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?
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 Bard Hydrophilic Coated Angiography Guide Wires are indicated for percutaneous entry into a vessel using the Seldinger technique.
The Bard Hydrophilic Coated Angioplasty (PTCA) Guide Wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary or peripheral vasculature and may be used to reach and cross a target lesion.
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/K993000 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993000: Bard Hydrophilic Coated Guide Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993000
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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