510(k) · Cleared
ClearedRoute 92 Medical Access System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Route 92 Medical, Inc. · DQY Catheter, Percutaneous
Cleared on May 23, 2018 as substantially equivalent to K163233 (Mivi Neuroscience, Inc., 2017) after a 119-day review. Its family tree reaches back 1 generation to 2017. 2 of the 11 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it.
- Decided
- May 23, 2018
- Review
- 119 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K163233 (2017). 9 later devices descend from it, 1 citing it directly. 2 of the 11 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK163233 MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT…Mivi Neuroscience, Inc. · 2017
- This deviceK180201 Route 92 Medical Access SystemRoute 92 Medical, Inc. · 2018
- Descendant · cites it directly · 8 of its ownK200121 Route 92 Medical 088 Access System, 110 cmRoute 92 Medical, Inc. · 2020
- Descendant · 2 generations on · 5 of its ownK201518 Route 92 Medical 088 Access SystemRoute 92 Medical · 2020
- Descendant · 3 generations on · 3 of its ownK210635 Route 92 Medical Full Length 088 Access SystemRoute 92 Medical, Inc. · 2021
- Descendant · 4 generations on · 2 of its ownK222743 Route 92 Medical Full Length 070 Access SystemRoute 92 Medical, Inc. · 2022 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK242051 VersaD Delivery CatheterUnity Medical, Inc. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K200121Route 92 Medical 088 Access System, 110 cmRoute 92 Medical, Inc. · 2020 · cites it directly8descendants
- K201518Route 92 Medical 088 Access SystemRoute 92 Medical · 2020 · 2 generations on5descendants
- K210635Route 92 Medical Full Length 088 Access SystemRoute 92 Medical, Inc. · 2021 · 3 generations on3descendants
- K222743Route 92 Medical Full Length 070 Access SystemRoute 92 Medical, Inc. · 2022 · 4 generations on2descendants
- K242051VersaD Delivery CatheterUnity Medical, Inc. · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K163233 | MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension… | Mivi Neuroscience, Inc. | 2017 | — |
| 0 (this device) | K180201 | Route 92 Medical Access System | Route 92 Medical, Inc. | 2018 | — |
| +1 | K200121 | Route 92 Medical 088 Access System, 110 cm | Route 92 Medical, Inc. | 2020 | — |
| +2 | K201518 | Route 92 Medical 088 Access System | Route 92 Medical | 2020 | — |
| +3 | K210635 | Route 92 Medical Full Length 088 Access System | Route 92 Medical, Inc. | 2021 | — |
| +4 | K222743 | Route 92 Medical Full Length 070 Access System | Route 92 Medical, Inc. | 2022 | Class I |
| +2 | K242051 | VersaD Delivery Catheter | Unity Medical, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 3 | 1 |
| 2021 | 1 | 0 |
| 2022 | 1 | 1 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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.
2 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 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 |
|---|---|---|---|
| * | K163233 | MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F…Summary page 4…Percutaneous Catheter (Product Code DQY, 21 CFR 870.1250) Legally Marketed Predicate Device: MIVI Mi-EXT Catheter (K163233) Device Description The Route 92 Medical Access System is comprised of an Access Catheter and a Delivery Catheter. The distal po… | 2017 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200121 | Route 92 Medical 088 Access System, 110 cm | 2020 | 8 |
Has anything in its family been recalled? (2 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.
- K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K222743Route 92 Medical Full Length 070 Access SystemRoute 92 Medical, Inc. · 2022 · 4 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 Route 92 Medical Access System is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180201: Route 92 Medical Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180201
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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