510(k) · Cleared
Recalled · Class I · 2022Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · DQO Catheter, Intravascular, Diagnostic
Cleared on Nov 8, 2019 as substantially equivalent to K141769 (Lightlab Imaging, Inc., 2014) after a 102-day review. Its family tree reaches back 2 generations to 2013. 1 of the 13 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Nov 8, 2019
- Review
- 102 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K123369 (2013). 10 later devices descend from it, 3 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK123369 Ilumien OptisLightlab Imaging, Inc. · 2013
- 1 generation backK141769 Optis Integrated System, Dragonfly Optis Imaging CatheterLightlab Imaging, Inc. · 2014
- This deviceK192019 Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1Abbott Medical · 2019
- Descendant · cites it directly · 4 of its ownK221257 SpectraWAVE Imaging SystemSpectrawave, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK210458 OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging SystemAbbott Medical · 2021
- Descendant · 2 generations on · 1 of its ownK230691 HyperVue™ Imaging SystemSpectrawave, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK230411 Dragonfly OpStar™ Imaging CatheterAbbott Medical · 2023
- Descendant · 2 generations on · 0 of its ownK253459 OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next…Abbott Medical · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K221257SpectraWAVE Imaging SystemSpectrawave, Inc. · 2023 · cites it directly4descendants
- K210458OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging SystemAbbott Medical · 2021 · cites it directly2descendants
- K230691HyperVue™ Imaging SystemSpectrawave, Inc. · 2023 · 2 generations on1descendant
- K230411Dragonfly OpStar™ Imaging CatheterAbbott Medical · 2023 · cites it directly1descendant
- K253459OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System…Abbott Medical · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K123369 | Ilumien Optis | Lightlab Imaging, Inc. | 2013 | — |
| −1 | K141769 | Optis Integrated System, Dragonfly Optis Imaging Catheter | Lightlab Imaging, Inc. | 2014 | — |
| 0 (this device) | K192019 | Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 | Abbott Medical | 2019 | — |
| +1 | K221257 | SpectraWAVE Imaging System | Spectrawave, Inc. | 2023 | — |
| +1 | K210458 | OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System | Abbott Medical | 2021 | — |
| +2 | K230691 | HyperVue™ Imaging System | Spectrawave, Inc. | 2023 | — |
| +1 | K230411 | Dragonfly OpStar™ Imaging Catheter | Abbott Medical | 2023 | — |
| +2 | K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging… | Abbott Medical | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 4 | 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 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 |
|---|---|---|---|
| * | K141769 | Optis Integrated System, Dragonfly Optis Imaging CatheterSummary page 4…oduct Code: DQO, NQQ Classification Product Regulation 21 CFR 870.1200 Number OPTIS Integrated System, Dragonfly OPTIS™ Imaging Catheter (K141769), cleared Predicate Device 18 August 2014 ILUMIEN OPTIS, OPTIS Integrated, OPTIS Mobile… | 2014 |
| † | K183320 | Ilumien Optis, Optis Integrated, Optis Mobile | 2019 |
What descends from it? (10)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 30, 2022 | Class I | Z-1095-2022 | Under Investigation by firm | There is a potential that the proximal marker may separate from the imaging catheter |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K221257 (Spectrawave, Inc., 2023) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K141769.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Dragonfly OpStar™ imaging catheter with OCT imaging system is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly OpStar Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OpStar Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass…
Read the full statement (227 words)
The Dragonfly OpStar™ imaging catheter with OCT imaging system is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly OpStar Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OpStar Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
The AptiVue™ E-series software is intended for use only with compatible OPTIS™ imaging systems. The OPTIS imaging system with a compatible Dragonfly™ imaging catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The compatible Dragonfly™ imaging catheters are intended for use in vessels 2.0 to 3.5 mm in diameter. The compatible Dragonfly™ imaging catheters are not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
The OPTIS imaging system is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192019: Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192019
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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