510(k) · Cleared
ClearedZenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inneuroco, Inc. · DQY Catheter, Percutaneous
Cleared on Jan 26, 2018 as substantially equivalent to K171672 (Inneuroco, Inc., 2017) after a 53-day review. Its family tree reaches back 9 generations to 2001.
- Decided
- Jan 26, 2018
- Review
- 53 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K010954 (2001). 20 ancestors in all, the oldest K010853 (2001). No later device cites it as a predicate yet.
- Root · 9 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 5 generations between
- 3 generations backK122772 Penumbra DDC CathetersPenumbra, Inc. · 2012
- 2 generations backK152202 Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm…Tni Manufacturing, Inc. · 2015
- 1 generation backK171672 065 Zenith, 074 ZenithInneuroco, Inc. · 2017
- This deviceK173709 Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cmInneuroco, Inc. · 2018
Show all 9 generations
- Root · 9 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 8 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- 7 generations backK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
- 6 generations backK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
- 5 generations backK082290 Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · Recalled
- 4 generations backK093970 Pica CatheterPenumbra, Inc. · 2010
- 3 generations backK122772 Penumbra DDC CathetersPenumbra, Inc. · 2012
- 2 generations backK152202 Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm…Tni Manufacturing, Inc. · 2015
- 1 generation backK171672 065 Zenith, 074 ZenithInneuroco, Inc. · 2017
- This deviceK173709 Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cmInneuroco, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −8 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| −7 | K053491 | Penumbra Balloon Guide Catheter, Model 7.5F | Penumbra, Inc. | 2006 | — |
| −6 | K070970 | Neuron Support Catheter System, Model 5F/6F | Penumbra, Inc. | 2007 | 1 |
| −5 | K082290 | Neuron Delivery Catheter 070 | Penumbra, Inc. | 2008 | 1 |
| −4 | K093970 | Pica Catheter | Penumbra, Inc. | 2010 | — |
| −3 | K122772 | Penumbra DDC Catheters | Penumbra, Inc. | 2012 | — |
| −2 | K152202 | Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate… | Tni Manufacturing, Inc. | 2015 | — |
| −1 | K171672 | 065 Zenith, 074 Zenith | Inneuroco, Inc. | 2017 | — |
| 0 (this device) | K173709 | Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm | Inneuroco, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 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? (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 |
|---|---|---|---|
| * | K171672 | 065 Zenith, 074 ZenithSummary page 5…Name of Predicate Device Name of Manufacturer 510(k) Number Zenith 074 InNeuroCo K171672 DEVICE DESCRIPTION The InNeuroCo Zenith Support product consists of a catheter, a hemostasis valve, and a split sheath introduc… | 2017 |
| † | K161262 | Super Distal Access (SDA) | 2016 |
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?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 9 of the 20 ancestors have a recall of any class.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Zenith Support Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173709 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173709: Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173709
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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