510(k) · Cleared
ClearedRoute 92 Medical Sheath 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 Jan 13, 2020 as substantially equivalent to K152876 (Tni Manufacturing, Inc., 2016) after a 201-day review. Its family tree reaches back 7 generations to 2001. 1 of the 12 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Jan 13, 2020
- Review
- 201 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K010954 (2001). 9 ancestors in all, the oldest K010853 (2001). 2 later devices descend from it, 2 citing it directly. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- 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 backK082290 Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · Recalled
- 2 generations backK111380 Neuron Max SystemPenumbra, Inc. · 2011
- 1 generation backK152876 Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or…Tni Manufacturing, Inc. · 2016 · Recalled
- This deviceK191717 Route 92 Medical Sheath SystemRoute 92 Medical, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK242376 Next Generation Access PlatformBalt USA, LLC · 2024 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK240529 8F Modified Sheath SystemRoute 92 Medical, Inc. · 2024
Class I recalls in this family
- K242376 Next Generation Access Platformcites it directly · 2024
Most influential descendants
Showing 2 of 2 · See allView 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 | K082290 | Neuron Delivery Catheter 070 | Penumbra, Inc. | 2008 | 1 |
| −2 | K111380 | Neuron Max System | Penumbra, Inc. | 2011 | — |
| −1 | K152876 | Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CM | Tni Manufacturing, Inc. | 2016 | 1 |
| 0 (this device) | K191717 | Route 92 Medical Sheath System | Route 92 Medical, Inc. | 2020 | — |
| +1 | K242376 | Next Generation Access Platform | Balt USA, LLC | 2024 | Class I |
| +1 | K240529 | 8F Modified Sheath System | Route 92 Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 1 |
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 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 |
|---|---|---|---|
| * | K152876 | Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CMSummary page 4…heter (Product Code DQY, 21 CFR 870.1250) Legally Marketed Predicate Device: TNI Manufacturing, Inc. Long Sheath (K152876) Device Description The Route 92 Medical Sheath System is comprised of a Sheath, a Dilator, a Navigating Catheter, and an RHV (r… | 2016 |
| † | K142819 | Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set | 2015 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K242376Next Generation Access PlatformBalt USA, LLC · 2024 · Cites it directly · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 7 of the 9 ancestors have a recall of any class.
- Of its descendants, K242376 (Balt USA, LLC, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K152876.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Sheath System 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/K191717 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191717: Route 92 Medical Sheath System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191717
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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