510(k) · Cleared
ClearedMongoose Angiographic Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pediacath, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Jul 11, 2012 as substantially equivalent to K943739 (Mallinckrodt Medical, 1994) and 1 other predicate after a 197-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it.
- Decided
- Jul 11, 2012
- Review
- 197 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K960806 (1996). 4 ancestors in all, the oldest K943739 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 2 generations backK032624 Micrus MicrocatheterMicrus Corp. · 2003
- 1 generation backK060116 Micrus Courier MicrocathetersMicrus Endovascular Corporation · 2006
- This deviceK113819 Mongoose Angiographic CatheterPediacath, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK171264 Royal Flush CatheterCook Incorporated · 2018
Most influential descendants
Showing 1 of 1 · See all- K171264Royal Flush CatheterCook Incorporated · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −2 | K032624 | Micrus Microcatheter | Micrus Corp. | 2003 | — |
| −1 | K060116 | Micrus Courier Microcatheters | Micrus Endovascular Corporation | 2006 | — |
| 0 (this device) | K113819 | Mongoose Angiographic Catheter | Pediacath, Inc. | 2012 | — |
| +1 | K171264 | Royal Flush Catheter | Cook Incorporated | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (2)
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 |
|---|---|---|---|
| * | K943739 | Softouch Diagnostic Intravascular CatheterSummary page 2…tic Intravascular Catheter Regulation Number 870.1200 Product Code 000 Classification Panel Cardiovascular Device Class Class 11 Predicate Devices 1. K943739: Softouch Diagnostic Intravascular Catheter (Merit Medical is currently responsible for marketing the device originally submi… | 1994 |
| * | K060116 | Micrus Courier MicrocathetersSummary page 2…touch Diagnostic Intravascular Catheter (Merit Medical is currently responsible for marketing the device originally submitted under this premarket notification). 2. K060116: Micrus Courier Microcatheters Indications for Use The Mongoose Angiographic Catheter is intended for the delivery of contrast m… | 2006 |
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 |
|---|---|---|---|
| K171264 | Royal Flush Catheter | 2018 | 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 16 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K171264 (Cook Incorporated, 2018) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K943739.
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 Mongoose Angiographic Catheter is intended for the delivery of contrast media to selected sites in the vascular system of adult and pediatric patients of all ages in conjunction with routine diagnostic procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K113819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113819: Mongoose Angiographic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113819
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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