510(k) · Cleared
ClearedSOFIA 6F Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MicroVention, Inc. · DQY Catheter, Percutaneous
Cleared on Mar 27, 2015 as substantially equivalent to K142014 (MicroVention, Inc., 2014) and 1 other predicate after a 43-day review. Its family tree reaches back 7 generations to 2001. 6 later devices descend from it.
- Decided
- Mar 27, 2015
- Review
- 43 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K010954 (2001). 14 ancestors in all, the oldest K925813 (1994). 6 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 6 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- 5 generations backK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
- 4 generations backK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
- 3 generations backK082385 Chaperon Guiding CatheterMicroVention, Inc. · 2008
- 2 generations backK131482 Sofia Distal Access CatheterMicroVention, Inc. · 2013
- 1 generation backK142014 Sofia Distal Access CatheterMicroVention, Inc. · 2014
- This deviceK150366 SOFIA 6F CatheterMicroVention, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK201682 RIST Radial Access CatheterRist Neurovascular, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK241388 Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2025
- Descendant · 3 generations on · 0 of its ownK254178 SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK231179 Slinky CatheterAnoxia Medical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK214024 SOFIA 88 CatheterMicroVention, Inc. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K201682RIST Radial Access CatheterRist Neurovascular, Inc. · 2020 · cites it directly2descendants
- K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2025 · 2 generations on1descendant
- K254178SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd. · 2026 · 3 generations on0descendants
- K231179Slinky CatheterAnoxia Medical, Inc. · 2023 · cites it directly0descendants
- K214024SOFIA 88 CatheterMicroVention, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −6 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| −5 | K053491 | Penumbra Balloon Guide Catheter, Model 7.5F | Penumbra, Inc. | 2006 | — |
| −4 | K070970 | Neuron Support Catheter System, Model 5F/6F | Penumbra, Inc. | 2007 | 1 |
| −3 | K082385 | Chaperon Guiding Catheter | MicroVention, Inc. | 2008 | — |
| −2 | K131482 | Sofia Distal Access Catheter | MicroVention, Inc. | 2013 | — |
| −1 | K142014 | Sofia Distal Access Catheter | MicroVention, Inc. | 2014 | — |
| 0 (this device) | K150366 | SOFIA 6F Catheter | MicroVention, Inc. | 2015 | — |
| +1 | K201682 | RIST Radial Access Catheter | Rist Neurovascular, Inc. | 2020 | — |
| +2 | K241388 | Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter… | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2025 | — |
| +3 | K254178 | SAYA 86 Radial Access Guide Catheter | Asahi Intecc Co., Ltd. | 2026 | — |
| +1 | K231179 | Slinky Catheter | Anoxia Medical, Inc. | 2023 | — |
| +1 | K214024 | SOFIA 88 Catheter | MicroVention, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K142014 | Sofia Distal Access CatheterSummary page 4…ornia U.S.A. Contact: Naomi Gong Date: 2015 February 11 Predicate Device: SOFIA Distal Access Catheter (K142014/K131482) Device Description: The SOFIA PLUS/Distal Access Catheters are a single-lumen, flexible catheter designed with coil and… | 2014 |
| * | K131482 | Sofia Distal Access CatheterSummary page 4…S.A. Contact: Naomi Gong Date: 2015 February 11 Predicate Device: SOFIA Distal Access Catheter (K142014/K131482) Device Description: The SOFIA PLUS/Distal Access Catheters are a single-lumen, flexible catheter designed with coil and braid r… | 2013 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 14 ancestors have a recall of any class.
- Of its descendants, K201682 (Rist Neurovascular, Inc., 2020) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K142014.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The SOFIA PLUS/Distal Access Catheters are indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic and therapeutic agents. It is not intended for use in coronary arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150366: SOFIA 6F Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150366
Report an extraction error
Are you the manufacturer?
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