510(k) · Cleared
Recalled · Class II · 2019Catheters for Balloon Occlusion Femoral Angiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · DYG Catheter, Flow Directed
Cleared on Sep 26, 1989 after a 168-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 16 devices in its family, counting itself, have a Class I recall. 15 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 26, 1989
- Review
- 168 days
- Class
- Class II
- Product code
- DYG
- Recalls
- 3
- Predicates
- 0
15 later devices descend from it, 1 citing it directly. 3 of the 16 devices in this family, counting this one, have a Class I recall.
- This deviceK892530 Catheters for Balloon Occlusion Femoral AngiographArrow Intl., Inc. · 1989
- Descendant · cites it directly · 14 of its ownK071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable…Arrow International, Inc. · 2007 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK121501 Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Arrow International (Subsidiary of Teleflex Inc.) · 2012
- Descendant · 2 generations on · 3 of its ownK190855 BD Acute Central LineBard Access Systems, Inc. (Bard Has Joined Bd) · 2019
- Descendant · 3 generations on · 3 of its ownK132133 CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK091709 Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKICEdwards Lifesciences, LLC · 2009
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 15 · See all- K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. · 2007 · cites it directly14descendants
- K121501Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Arrow International (Subsidiary of Teleflex Inc.) · 2012 · 2 generations on4descendants
- K190855BD Acute Central LineBard Access Systems, Inc. (Bard Has Joined Bd) · 2019 · 2 generations on3descendants
- K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 3 generations on3descendants
- K091709Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKICEdwards Lifesciences, LLC · 2009 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K892530 | Catheters for Balloon Occlusion Femoral Angiograph | Arrow Intl., Inc. | 1989 | — |
| +1 | K071538 | Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous… | Arrow International, Inc. | 2007 | Class I |
| +2 | K121501 | Arrow Jugular Axillo-Subclavian Central Catheter (Jacc) | Arrow International (Subsidiary of Teleflex Inc.) | 2012 | — |
| +2 | K190855 | BD Acute Central Line | Bard Access Systems, Inc. (Bard Has Joined Bd) | 2019 | — |
| +3 | K132133 | CG+ Arrow Jacc Powered by Arrow VPS Stylet | Arrow International (Subsidiary of Teleflex Inc.) | 2013 | Class I |
| +2 | K091709 | Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKIC | Edwards Lifesciences, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 1 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 1 |
| 2015 | 1 | 0 |
| 2016 | 4 | 1 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have 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 DYG device
- #1 K242451 HemoSphere Alta Advanced Monitoring Platform…score 24.2 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071538 | Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous Catheter Class I | 2007 | 14 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 15, 2019 | Class II | Z-0715-2020 | Process control | Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by… |
| Nov 15, 2019 | Class II | Z-0716-2020 | Process control | Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by… |
| Mar 4, 2013 | Class II | Z-1057-2013 | Labeling Change Control | The product specifications sheet, part of the Instructions for Use (IFU), for the specified product numbers, reference Renografin-76 contrast medium (viscosity of 8.4 centipoise), which is no longer available. Firm is in the process of… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 15 Class I recalls
- K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K071538 (Arrow International, Inc., 2007) has gone furthest, with 14 descendants of its own.
How does its category compare?
All DYG devicesDYG Catheter, Flow Directed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYG
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DYG
188in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYG
2in 2019
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DYG
268in 2025
MAUDE reports naming product code DYG, 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 | 0 | — | 1 | 168 |
| 2008 | 1 | — | 0 | 400 |
| 2009 | 0 | — | 3 | 145 |
| 2010 | 0 | — | 0 | 147 |
| 2011 | 1 | — | 0 | 249 |
| 2012 | 0 | — | 0 | 221 |
| 2013 | 0 | — | 1 | 149 |
| 2014 | 0 | — | 0 | 178 |
| 2015 | 0 | — | 0 | 163 |
| 2016 | 1 | — | 0 | 154 |
| 2017 | 0 | — | 0 | 115 |
| 2018 | 0 | — | 4 (4) | 133 |
| 2019 | 0 | — | 2 | 144 |
| 2020 | 1 | — | 0 | 104 |
| 2021 | 0 | — | 0 | 97 |
| 2022 | 1 | — | 0 | 130 |
| 2023 | 1 | — | 0 | 229 |
| 2024 | 3 | 188 | 0 | 226 |
| 2025 | 0 | — | 0 | 268 |
| 2026 | 0 | — | 2 | — |
https://510kreport.com/device/K892530 · printed Nov 5, 2026
Cite this page
510(k) Report. “K892530: Catheters for Balloon Occlusion Femoral Angiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K892530
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026