510(k) · Cleared
ClearedSequitor Steerable Guidewire, Models SQR18XX and SQR14XX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosphere Medical, Inc. · DQX Wire, Guide, Catheter
Cleared on Jun 2, 2006 as substantially equivalent to K011287 (Radius Medical Technologies, Inc., 2001) and 2 other predicates after a 36-day review. Its family tree reaches back 2 generations to 1995. 5 of the 42 devices in its family, counting itself, have a Class I recall. 36 later devices descend from it.
- Decided
- Jun 2, 2006
- Review
- 36 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K950113 (1995). 5 ancestors in all. 36 later devices descend from it, 1 citing it directly. 5 of the 42 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK950113 Scimed (R) Chice (TM) Exchange Ptca Guide WireScimed Life Systems, Inc. · 1995
- 1 generation backK022357 Transend 300 ES Guidewire, Model 46-814 & Transend 300 Floppy…Boston Scientific, Target · 2002
- This deviceK061171 Sequitor Steerable Guidewire, Models SQR18XX and SQR14XXBiosphere Medical, Inc. · 2006
- Descendant · cites it directly · 35 of its ownK062192 Ostial Pro Stent Positioning SystemOstial Solutions, LLC · 2007
- Descendant · 2 generations on · 30 of its ownK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- Descendant · 3 generations on · 15 of its ownK110256 The IC-Pro SystemPaieon, Inc. · 2011
- Descendant · 3 generations on · 13 of its ownK100292 Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010
- Descendant · 3 generations on · 11 of its ownK091781 Guided Medical Positioning System (GMPS)Mediguide, Ltd. · 2009
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K190106 Intra-Operative Positioning System; Simple Curve…5 generations on · 2019
- K242133 Intra-Operative Positioning System (IOPS®)…6 generations on · 2024
- K241243 Intra-Operative Positioning System (IOPS®)…6 generations on · 2024
- K230309 Intra-Operative Positioning System (IOPS®)…6 generations on · 2023
Most influential descendants
Showing 5 of 36 · See all- K062192Ostial Pro Stent Positioning SystemOstial Solutions, LLC · 2007 · cites it directly35descendants
- K083745The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009 · 2 generations on30descendants
- K110256The IC-Pro SystemPaieon, Inc. · 2011 · 3 generations on15descendants
- K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010 · 3 generations on13descendants
- K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd. · 2009 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950113 | Scimed (R) Chice (TM) Exchange Ptca Guide Wire | Scimed Life Systems, Inc. | 1995 | — |
| −1 | K022357 | Transend 300 ES Guidewire, Model 46-814 & Transend 300 Floppy Guidewire, Model… | Boston Scientific, Target | 2002 | — |
| 0 (this device) | K061171 | Sequitor Steerable Guidewire, Models SQR18XX and SQR14XX | Biosphere Medical, Inc. | 2006 | — |
| +1 | K062192 | Ostial Pro Stent Positioning System | Ostial Solutions, LLC | 2007 | — |
| +2 | K083745 | The IC-Pro System, Model Version 3.2 | Paieon, Inc. | 2009 | — |
| +3 | K110256 | The IC-Pro System | Paieon, Inc. | 2011 | — |
| +3 | K100292 | Caas Qva 3D, Caas Qca 3D | Pie Medical Imaging BV | 2010 | — |
| +3 | K091781 | Guided Medical Positioning System (GMPS) | Mediguide, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 6 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 1 |
| 2021 | 1 | 0 |
| 2023 | 3 | 1 |
| 2024 | 3 | 2 |
| 2025 | 4 | 1 |
| 2026 | 3 | 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.
5 devices in this family have 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? (3)
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 |
|---|---|---|---|
| * | K011287 | Radius Cougar Wire | 2001 |
| * | K032129 | Radius 018 Cougar WireSummary page 1…Common/Usual Name: Vascular Guidewire Classification Name: Catheter Guidewire 3. PREDICATE DEVICES * Radius Medical Cougar Guidewire (KO11287 AND K032129) * Boston Scientific Corporation, Transend Guidewire (K022357) 4. DEVICE DESCRIPTION The SequitorTM Steera… | 2003 |
| * | K022357 | Transend 300 ES Guidewire, Model 46-814 & Transend 300 Floppy Guidewire, Model 46-815Summary page 1…ter Guidewire 3. PREDICATE DEVICES * Radius Medical Cougar Guidewire (KO11287 AND K032129) * Boston Scientific Corporation, Transend Guidewire (K022357) 4. DEVICE DESCRIPTION The SequitorTM Steerable Guidewire (.014" or .018") is a stainless steel guidewire wi… | 2002 |
What descends from it? (36)
See all 361 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062192 | Ostial Pro Stent Positioning System | 2007 | 35 |
Has anything in its family been recalled? (5 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.
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 6 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 6 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 6 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K062192 (Ostial Solutions, LLC, 2007) has gone furthest, with 35 descendants of its own.
- 3 other devices also cite its predicate K011287.
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 Sequitor™ Steerable Guidewire is intended to facilitate the placement of catheters within the peripheral vasculature for various diagnostic and interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061171 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061171: Sequitor Steerable Guidewire, Models SQR18XX and SQR14XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061171
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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