510(k) · Cleared
ClearedIntroducer for Ptca Guiding Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Argon Medical Corp. · DYB Introducer, Catheter
Cleared on May 19, 1989 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- May 19, 1989
- Review
- 80 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK891022 Introducer for Ptca Guiding CathetersArgon Medical Corp. · 1989
- Descendant · cites it directly · 11 of its ownK963388 Vessel DilatorMaxxim Medical · 1997
- Descendant · 2 generations on · 10 of its ownK070749 Estech Percutaneous Insertion Dilator KitCoombs Medical Device Consulting · 2007
- Descendant · 3 generations on · 4 of its ownK081940 Avalon Elite Vascular Access KitAvalon Laboratories, LLC · 2008 · Recalled
- Descendant · 2 generations on · 2 of its ownK093554 Retroflex Dilator KitEdwards Lifesciences, LLC · 2010
- Descendant · 4 generations on · 1 of its ownK162181 Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetCardiacassist, Inc. · 2017 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K963388Vessel DilatorMaxxim Medical · 1997 · cites it directly11descendants
- K070749Estech Percutaneous Insertion Dilator KitCoombs Medical Device Consulting · 2007 · 2 generations on10descendants
- K081940Avalon Elite Vascular Access KitAvalon Laboratories, LLC · 2008 · 3 generations on4descendants
- K093554Retroflex Dilator KitEdwards Lifesciences, LLC · 2010 · 2 generations on2descendants
- K162181Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetCardiacassist, Inc. · 2017 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K891022 | Introducer for Ptca Guiding Catheters | Argon Medical Corp. | 1989 | — |
| +1 | K963388 | Vessel Dilator | Maxxim Medical | 1997 | — |
| +2 | K070749 | Estech Percutaneous Insertion Dilator Kit | Coombs Medical Device Consulting | 2007 | — |
| +3 | K081940 | Avalon Elite Vascular Access Kit | Avalon Laboratories, LLC | 2008 | 1 |
| +2 | K093554 | Retroflex Dilator Kit | Edwards Lifesciences, LLC | 2010 | — |
| +4 | K162181 | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set | Cardiacassist, Inc. | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2025 | 2 | 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.
Planning a device in DYB? 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 DYB device
- #1 K251051 AuST Steerable Sheathscore 18.0 · 10 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? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K963388 | Vessel Dilator | 1997 | 11 |
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?
- Of its descendants, K963388 (Maxxim Medical, 1997) has gone furthest, with 11 descendants of its own.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, 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 | 12 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (21) | — |
https://510kreport.com/device/K891022 · printed Nov 4, 2026
Cite this page
510(k) Report. “K891022: Introducer for Ptca Guiding Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K891022
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026