510(k) · Cleared
ClearedStent Positioning Assistance System (SPAS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seven Sons, Ltd. · DQX Wire, Guide, Catheter
Cleared on Aug 19, 2022 as substantially equivalent to K141054 (Distal Access, LLC, 2014) after a 50-day review. Its family tree reaches back 8 generations to 1985. 1 of the 18 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 19, 2022
- Review
- 50 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K854261 (1985). 17 ancestors in all. No later device cites it as a predicate yet. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK854261 Advanced Cardiovascular Systems Hemostatic ValvesAdvanced Cardiovascular Systems, Inc. · 1985 · Recalled
- 7 generations backK991102 Copilot Bleedback Control Valve, Model 1003331Guidant Corp. · 1999 · Recalled
- 6 generations backK042060 Easypass US Y-Connector Hemostatic ValveMillimed A/S · 2004
- 5 generations backK052381 Guardian Hemostasis Valve with Guidewire IntroducerZerusa Limited · 2005
- 4 generations backK073620 Guardian Hemostasis ValveZerusa Limited · 2008
- 3 generations backK092711 Guardian II Hemostasis ValveZerusa Limited · 2009 · Recalled (Class I)
- 2 generations backK100093 Vsi Torque DeviceVascular Solutions, Inc. · 2010
- 1 generation backK141054 Distal Access Torque DeviceDistal Access, LLC · 2014
- This deviceK221917 Stent Positioning Assistance System (SPAS)Seven Sons, Ltd. · 2022
Class I recalls in this family
- K092711 Guardian II Hemostasis Valve3 generations back · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K854261 | Advanced Cardiovascular Systems Hemostatic Valves | Advanced Cardiovascular Systems, Inc. | 1985 | 2 |
| −7 | K991102 | Copilot Bleedback Control Valve, Model 1003331 | Guidant Corp. | 1999 | 1 |
| −6 | K042060 | Easypass US Y-Connector Hemostatic Valve | Millimed A/S | 2004 | — |
| −5 | K052381 | Guardian Hemostasis Valve with Guidewire Introducer | Zerusa Limited | 2005 | — |
| −4 | K073620 | Guardian Hemostasis Valve | Zerusa Limited | 2008 | — |
| −3 | K092711 | Guardian II Hemostasis Valve | Zerusa Limited | 2009 | Class I |
| −2 | K100093 | Vsi Torque Device | Vascular Solutions, Inc. | 2010 | — |
| −1 | K141054 | Distal Access Torque Device | Distal Access, LLC | 2014 | — |
| 0 (this device) | K221917 | Stent Positioning Assistance System (SPAS) | Seven Sons, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K141054 | Distal Access Torque DeviceSummary page 4…(Predict or Spinr) Device: Manufacturer: Distal Access, LLC 510(k) Clearance: K141054 Classification Name: Catheter Guide Wire 21CFR §870.1330… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K092711Guardian II Hemostasis ValveZerusa Limited · 2009 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 37 years and passes through 7 companies; a new generation was cleared every 4.6 years on median.
- 4 of the 17 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K141054.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
SPAS is an adjunct device intended to be used to maneuver endo-vascular stent delivery systems and support their positioning in Percutaneous Coronary Interventions (PCI). SPAS is not intended for use in neurovascular interventional procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221917 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221917: Stent Positioning Assistance System (SPAS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221917
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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