510(k) · Cleared
Cleared0.014 Inch Extra Long Floppy and 0.014 Extra Long Intermediate Guide Wires with Phosphorylcholine (PC) Polymer Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocompatibles Cardiovascular, Inc. · DQX Wire, Guide, Catheter
Cleared on Sep 10, 1996 as substantially equivalent to K955135 (Biocompatibles, Ltd., 1996) after a 90-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Sep 10, 1996
- Review
- 90 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955135 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK955135 0.014 Intermediate Guide Wire W/Phosphorylcholine Polymer CoatingBiocompatibles, Ltd. · 1996
- This deviceK962266 0.014 Inch Extra Long Floppy and 0.014 Extra Long Intermediate Guide…Biocompatibles Cardiovascular, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955135 | 0.014 Intermediate Guide Wire W/Phosphorylcholine Polymer Coating | Biocompatibles, Ltd. | 1996 | — |
| 0 (this device) | K962266 | 0.014 Inch Extra Long Floppy and 0.014 Extra Long Intermediate Guide Wires… | Biocompatibles Cardiovascular, Inc. | 1996 | — |
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? (1)
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 |
|---|---|---|---|
| * | K955135 | 0.014 Intermediate Guide Wire W/Phosphorylcholine Polymer CoatingSummary page 1…m Radiopaque Tip Guide Wire - Catheter Guide Wire (21 CFR 870.1330) Biocompatibles 0.014" Floppy and Intermediate Guide Wires with Phosphoryicholine Polymer Coating (K955135 - SE Determination on April 9, 1996) The Floppy (2) and Intermediate (2) Extra Long Guide Wires have a nominal outside diameter… | 1996 |
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?
- Its one ancestor has no recall.
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 Floppy and Intermediate Extra Long Guide Wires are intended for use to facilitate the placement of PTA and/or PTCA balloon dilatation catheters within the peripheral or coronary vasculature. The guide wires are designed for safe use with appropriately sized balloon catheters. The guide wires are not intended for use in the 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/K962266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962266: 0.014 Inch Extra Long Floppy and 0.014 Extra Long Intermediate Guide Wires with Phosphorylcholine (PC) Polymer Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962266
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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