510(k) · Cleared
ClearedAPRO 55 Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alembic, LLC · DQY Catheter, Percutaneous
Cleared on Mar 15, 2024 as substantially equivalent to K151667 (Stryker, 2015) after a 79-day review. Its family tree reaches back 6 generations to 2001. 4 later devices descend from it.
- Decided
- Mar 15, 2024
- Review
- 79 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K003880 (2001). 10 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK003880 Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021…Concentric Medical, Inc. · 2001
- 5 generations backK080583 Modified HD Guide CatheterConcentric Medical, Inc. · 2008
- 4 generations backK090335 HD Guide CatheterConcentric Medical, Inc. · 2009
- 3 generations backK110483 Modified HD Guide CatheterConcentric Medical, Inc. · 2011 · Recalled
- 2 generations backK133177 Modified HD Guide CatheterConcentric Medical, Inc. · 2014 · Recalled
- 1 generation backK151667 AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal…Stryker · 2015 · Recalled
- This deviceK234115 APRO 55 CatheterAlembic, LLC · 2024
- Descendant · cites it directly · 1 of its ownK251014 APRO 45 CatheterAlembic, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK262392 APRO 35 Swift CatheterAlembic, LLC · 2026
- Descendant · cites it directly · 0 of its ownK250962 APRO 55 Intermediate CatheterAlembic, LLC · 2025
- Descendant · cites it directly · 0 of its ownK243297 APRO 70 Swift CatheterAlembic, LLC · 2025
Most influential descendants
Showing 4 of 4 · See all- K251014APRO 45 CatheterAlembic, LLC · 2025 · cites it directly1descendant
- K262392APRO 35 Swift CatheterAlembic, LLC · 2026 · 2 generations on0descendants
- K250962APRO 55 Intermediate CatheterAlembic, LLC · 2025 · cites it directly0descendants
- K243297APRO 70 Swift CatheterAlembic, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003880 | Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021 (6F), 90022… | Concentric Medical, Inc. | 2001 | — |
| −5 | K080583 | Modified HD Guide Catheter | Concentric Medical, Inc. | 2008 | — |
| −4 | K090335 | HD Guide Catheter | Concentric Medical, Inc. | 2009 | — |
| −3 | K110483 | Modified HD Guide Catheter | Concentric Medical, Inc. | 2011 | 1 |
| −2 | K133177 | Modified HD Guide Catheter | Concentric Medical, Inc. | 2014 | 3 |
| −1 | K151667 | AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access… | Stryker | 2015 | 3 |
| 0 (this device) | K234115 | APRO 55 Catheter | Alembic, LLC | 2024 | — |
| +1 | K251014 | APRO 45 Catheter | Alembic, LLC | 2025 | — |
| +2 | K262392 | APRO 35 Swift Catheter | Alembic, LLC | 2026 | — |
| +1 | K250962 | APRO 55 Intermediate Catheter | Alembic, LLC | 2025 | — |
| +1 | K243297 | APRO 70 Swift Catheter | Alembic, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 3 | 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 K250828 CPS Locator 3D Plus Delivery Catheterscore 15.9 · 12 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 |
|---|---|---|---|
| * | K151667 | AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter…Summary page 4…DQY, QJP Review Panel: Cardiovascular, Neurology 3) Legally Marketed Predicate Device and Reference Device Predicate Device: K151667 AXS Catalyst Distal Access Catheter Reference Device: K223545 APRO 70 Catheter and Alembic Aspiration Tubing 4… | 2015 |
| † | K223545 | APRO 70 Catheter and Alembic Aspiration Tubing | 2023 |
What descends from it? (4)
3 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 23 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 6 of the 10 ancestors have a recall of any class.
- Of its descendants, K251014 (Alembic, LLC, 2025) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K151667.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 APRO 55 Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The APRO 55 Catheter is also indicated for use as a conduit for retrieval devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K234115: APRO 55 Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K234115
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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