510(k) · Cleared
Recalled · 2009Sniper Elite Model-or-E3872XX Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxxim Medical · DQX Wire, Guide, Catheter
Cleared on Aug 28, 2001 as substantially equivalent to K832030 (Argon Medical Corp., 1983) after a 70-day review. Its family tree reaches back 1 generation to 1983. It has been recalled 52 times.
- Decided
- Aug 28, 2001
- Review
- 70 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 52
- Predicates
- 1
Its longest line of descent runs back 1 generation to K832030 (1983). No later device cites it as a predicate yet.
- Root · 1 generation backK832030 Heparin Coated Stainless Steel/TeflonArgon Medical Corp. · 1983
- This deviceK011905 Sniper Elite Model-or-E3872XX SeriesMaxxim Medical · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K832030 | Heparin Coated Stainless Steel/Teflon | Argon Medical Corp. | 1983 | — |
| 0 (this device) | K011905 | Sniper Elite Model-or-E3872XX Series | Maxxim Medical | 2001 | — |
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 |
|---|---|---|---|
| * | K832030 | Heparin Coated Stainless Steel/TeflonSummary page 1…ail Doherty, Compliance Manager Legally marketed devices to which equivalence is claimed: Maxxim Medical Heparin Coated Stainless Steel/Teflon Coated Spring Guidewire, K832030 Description of Device: The Sniper Elite™ Hydrophilic Guidewire is constructed from a super elastic, Nitinol core wire. A plasti… | 1983 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 25, 2009 | Not classified | Z-0623-2010 | Process control | Some of the guidewires in these two lots have a straight tip (incorrect) rather than an angled tip (correct configuration for that catalog number). |
| Feb 26, 2009 | Not classified | Z-1296-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1289-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1304-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1298-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1278-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1306-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1293-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1300-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1301-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1305-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1303-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1281-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1271-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1267-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1276-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1286-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1282-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1270-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1287-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1274-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1275-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1297-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1299-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1272-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1285-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1268-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1307-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1284-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1277-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1269-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1273-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1288-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1291-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1302-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1290-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1279-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1283-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1294-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1292-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1280-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Feb 26, 2009 | Not classified | Z-1295-2009 | Other | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Nov 19, 2007 | Not classified | Z-0886-2008 | Process design | Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism. |
| Nov 19, 2007 | Not classified | Z-0882-2008 | Process design | Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism. |
| Nov 19, 2007 | Not classified | Z-0888-2008 | Process design | Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism. |
| Nov 19, 2007 | Not classified | Z-0890-2008 | Process design | Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism. |
| Nov 19, 2007 | Not classified | Z-0884-2008 | Process design | Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism. |
| Nov 19, 2007 | Not classified | Z-0889-2008 | Process design | Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism. |
| Nov 19, 2007 | Not classified | Z-0891-2008 | Process design | Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism. |
| Nov 19, 2007 | Not classified | Z-0883-2008 | Process design | Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism. |
The 5 latest of 50 recalls; the web page lists all.
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
2007high 21 (2010) · low 6 (2021)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
2007high 212 (2022) · low 43 (2011)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
2007high 49 (2009) · low 0 (2014)2026
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
2007high 2,210 (2024) · low 687 (2009)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?
Sniper Elite Hydrophilic Guidewires are designed for use in angiographic procedures to introduce/position catheters and interventional devices within the 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/K011905 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011905: Sniper Elite Model-or-E3872XX Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011905
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026