510(k) · Cleared
ClearedPhenom 27 Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cathera, Inc. · DQY Catheter, Percutaneous
Cleared on Jun 11, 2018 as substantially equivalent to K151638 (Cathera, Inc., 2015) after a 60-day review. Its family tree reaches back 5 generations to 1995. 4 later devices descend from it.
- Decided
- Jun 11, 2018
- Review
- 60 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K945904 (1995). 11 ancestors in all, the oldest K862117 (1986). 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK945904 Scimed (R) Venture (TM) II Infusion CatheterScimed Peripheral Interventions · 1995
- 4 generations backK972518 Transit/Rapidtransit/Speedster/Prowler Infusion CatheterCordis Neurovascular, Inc. · 1997
- 3 generations backK020680 Prowler Select 10 and 14 Infusion Catheters with and Without…Cordis Neurovascular, Inc. · 2002
- 2 generations backK021591 Prowler Select (10, 14, and Plus) Infusion Catheters with and…Cordis Neurovascular, Inc. · 2002 · Recalled
- 1 generation backK151638 Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom…Cathera, Inc. · 2015
- This deviceK180959 Phenom 27 CatheterCathera, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK210230 Phenom CathetersMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular · 2021
- Descendant · 2 generations on · 0 of its ownK260199 SLIM MicrocatheterBalt USA, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK251668 SurfRider 13 MicrocatheterKaneka Americas Holding, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK222023 RayFlowHexacath · 2023
Most influential descendants
Showing 4 of 4 · See all- K210230Phenom CathetersMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular · 2021 · cites it directly2descendants
- K260199SLIM MicrocatheterBalt USA, LLC · 2026 · 2 generations on0descendants
- K251668SurfRider 13 MicrocatheterKaneka Americas Holding, Inc. · 2026 · 2 generations on0descendants
- K222023RayFlowHexacath · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945904 | Scimed (R) Venture (TM) II Infusion Catheter | Scimed Peripheral Interventions | 1995 | — |
| −4 | K972518 | Transit/Rapidtransit/Speedster/Prowler Infusion Catheter | Cordis Neurovascular, Inc. | 1997 | — |
| −3 | K020680 | Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped Tips | Cordis Neurovascular, Inc. | 2002 | — |
| −2 | K021591 | Prowler Select (10, 14, and Plus) Infusion Catheters with and Without… | Cordis Neurovascular, Inc. | 2002 | 2 |
| −1 | K151638 | Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter | Cathera, Inc. | 2015 | — |
| 0 (this device) | K180959 | Phenom 27 Catheter | Cathera, Inc. | 2018 | — |
| +1 | K210230 | Phenom Catheters | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | 2021 | — |
| +2 | K260199 | SLIM Microcatheter | Balt USA, LLC | 2026 | — |
| +2 | K251668 | SurfRider 13 Microcatheter | Kaneka Americas Holding, Inc. | 2026 | — |
| +1 | K222023 | RayFlow | Hexacath | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K151638 | Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus CatheterSummary page 4…utaneous Catheter (21 CFR 870.1250, Product Code DQY) Continuous Flush Catheter (21 CFR 870.1210, Product Code KRA) Predicate Devices: Phenom® 27 Catheter (510K # K151638) Device Description: The Phenom® 27 Catheters are variable stiffness, single lumen catheters designed to access small, tortuous… | 2015 |
What descends from it? (4)
2 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 2.6 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K210230 (Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular, 2021) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K151638.
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?
Phenom® Catheters are intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculatures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180959 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180959: Phenom 27 Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180959
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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