510(k) · Cleared
ClearedPlato Microcath 27 Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scientia Vascular, LLC · DQO Catheter, Intravascular, Diagnostic
Cleared on Jul 30, 2012 as substantially equivalent to K993672 (Micro Therapeutics, Inc., 2000) after a 47-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- Jul 30, 2012
- Review
- 47 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K974473 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK974473 Easy Rider Micro CatheterMicro Therapeutics, Inc. · 1998
- 1 generation backK993672 Rebar Micro Catheter, Models 105-5080, 105-5086Micro Therapeutics, Inc. · 2000
- This deviceK121734 Plato Microcath 27 MicrocatheterScientia Vascular, LLC · 2012
- Descendant · cites it directly · 0 of its ownK143398 Plato MICROCATH 27B MicrocatheterScientia Vascular, LLC · 2015
Most influential descendants
Showing 1 of 1 · See all- K143398Plato MICROCATH 27B MicrocatheterScientia Vascular, LLC · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974473 | Easy Rider Micro Catheter | Micro Therapeutics, Inc. | 1998 | — |
| −1 | K993672 | Rebar Micro Catheter, Models 105-5080, 105-5086 | Micro Therapeutics, Inc. | 2000 | — |
| 0 (this device) | K121734 | Plato Microcath 27 Microcatheter | Scientia Vascular, LLC | 2012 | — |
| +1 | K143398 | Plato MICROCATH 27B Microcatheter | Scientia Vascular, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 DQO? 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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 |
|---|---|---|---|
| * | K993672 | Rebar Micro Catheter, Models 105-5080, 105-5086Summary page 1…ROCATH'D 27 Mierocatheter Common Name: Microcatheter Classification Name: Percutaneous catheter per 21 CFR 870.1200, DQO Predicate Device: ev3 Rebar-027, K993672 Device Description: The Plato MICROCATH® 27 Microcatheters are single lumen catheters designed to be use… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143398 | Plato MICROCATH 27B Microcatheter | 2015 | 0 |
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 14 years and passes through 2 companies; a new generation was cleared every 12.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K143398 (Scientia Vascular, LLC, 2015) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K993672.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The Plato MICROCATH® 27 Microcatheter is intended to assist in the delivery of diagnostic and/or therapeutic agents to the peripheral and neurovascular systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121734 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121734: Plato Microcath 27 Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121734
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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