510(k) · Cleared
ClearedRoute 92 Medical Full Length 088 Access System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Route 92 Medical, Inc. · QJP Catheter, Percutaneous, Neurovasculature
Cleared on Jul 27, 2021 as substantially equivalent to K201518 (Route 92 Medical, 2020) after a 146-day review. Its family tree reaches back 9 generations to 2001. 1 of the 20 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Jul 27, 2021
- Review
- 146 days
- Class
- Class II
- Product code
- QJP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K010954 (2001). 16 ancestors in all, the oldest K010853 (2001). 3 later devices descend from it, 1 citing it directly. 1 of the 20 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 5 generations between
- 3 generations backK180169 EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths…Imperative Care, Inc. · 2018
- 2 generations backK200121 Route 92 Medical 088 Access System, 110 cmRoute 92 Medical, Inc. · 2020
- 1 generation backK201518 Route 92 Medical 088 Access SystemRoute 92 Medical · 2020
- This deviceK210635 Route 92 Medical Full Length 088 Access SystemRoute 92 Medical, Inc. · 2021
- Descendant · cites it directly · 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 ownK231583 Route 92 Medical Full Length 054 Access SystemRoute 92 Medical, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK260220 Route 92 Medical Full Length 046 Access SystemRoute 92 Medical, Inc. · 2026
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 backK111380 Neuron Max SystemPenumbra, Inc. · 2011
- 3 generations backK180169 EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths…Imperative Care, Inc. · 2018
- 2 generations backK200121 Route 92 Medical 088 Access System, 110 cmRoute 92 Medical, Inc. · 2020
- 1 generation backK201518 Route 92 Medical 088 Access SystemRoute 92 Medical · 2020
- This deviceK210635 Route 92 Medical Full Length 088 Access SystemRoute 92 Medical, Inc. · 2021
Class I recalls in this family
- K222743 Route 92 Medical Full Length 070 Access Systemcites it directly · 2022
Most influential descendants
Showing 3 of 3 · See all- K222743Route 92 Medical Full Length 070 Access SystemRoute 92 Medical, Inc. · 2022 · cites it directly2descendants
- K231583Route 92 Medical Full Length 054 Access SystemRoute 92 Medical, Inc. · 2023 · 2 generations on1descendant
- K260220Route 92 Medical Full Length 046 Access SystemRoute 92 Medical, Inc. · 2026 · 3 generations on0descendants
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 | K111380 | Neuron Max System | Penumbra, Inc. | 2011 | — |
| −3 | K180169 | EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay… | Imperative Care, Inc. | 2018 | — |
| −2 | K200121 | Route 92 Medical 088 Access System, 110 cm | Route 92 Medical, Inc. | 2020 | — |
| −1 | K201518 | Route 92 Medical 088 Access System | Route 92 Medical | 2020 | — |
| 0 (this device) | K210635 | Route 92 Medical Full Length 088 Access System | Route 92 Medical, Inc. | 2021 | — |
| +1 | K222743 | Route 92 Medical Full Length 070 Access System | Route 92 Medical, Inc. | 2022 | Class I |
| +2 | K231583 | Route 92 Medical Full Length 054 Access System | Route 92 Medical, Inc. | 2023 | — |
| +3 | K260220 | Route 92 Medical Full Length 046 Access System | Route 92 Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 1 |
| 2023 | 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.
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 QJP device
- #1 K212838 Benchmark Intracranial Access Systemscore 16.9 · 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 |
|---|---|---|---|
| * | K201518 | Route 92 Medical 088 Access SystemSummary page 4…QJP, 21 CFR 870.1250) Device Classification: Class II Predicate Device: Route 92 Medical 088 Access System, K201518 Device Description The Route 92 Medical Full Length 088 Access System is comprised of a Support Catheter and a Delivery Cathete… | 2020 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222743 | Route 92 Medical Full Length 070 Access System Class I | 2022 | 2 |
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.
- K222743Route 92 Medical Full Length 070 Access SystemRoute 92 Medical, Inc. · 2022 · Cites it directly · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 16 ancestors have a recall of any class.
- Of its descendants, K222743 (Route 92 Medical, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K201518.
How does its category compare?
All QJP devicesQJP Catheter, Percutaneous, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QJP
22so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QJP
116in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QJP
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QJP
688in 2025
MAUDE reports naming product code QJP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 9 | 72 | 0 | 16 |
| 2021 | 12 | 139 | 0 | 29 |
| 2022 | 14 | 206 | 0 | 30 |
| 2023 | 14 | 184 | 0 | 75 |
| 2024 | 18 | 188 | 1 | 130 |
| 2025 | 14 | 116 | 0 | 688 |
| 2026 | 22 | 141 | 0 | — |
What is it indicated for?
The Route 92 Medical Full Length 088 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/K210635 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210635: Route 92 Medical Full Length 088 Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210635
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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