510(k) · Cleared
ClearedKodiak™ Dual Port Coaxial Introducer Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Argon Medical Devices · DYB Introducer, Catheter
Cleared on May 22, 2023 as substantially equivalent to K171999 (Cook Incorporated, 2017) after a 76-day review. Its family tree reaches back 1 generation to 2017.
- Decided
- May 22, 2023
- Review
- 76 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K171999 (2017). No later device cites it as a predicate yet.
- Root · 1 generation backK171999 Performer IntroducerCook Incorporated · 2017 · Recalled
- This deviceK230631 Kodiak™ Dual Port Coaxial Introducer KitArgon Medical Devices · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K171999 | Performer Introducer | Cook Incorporated | 2017 | 2 |
| 0 (this device) | K230631 | Kodiak™ Dual Port Coaxial Introducer Kit | Argon Medical Devices | 2023 | — |
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 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? (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 |
|---|---|---|---|
| * | K171999 | Performer IntroducerSummary page 4…name Catheter Introducer Classification number 21 CFR 870. 1340 Primary product code DYB Regulatory class II Predicate device Performer Introducer (K171999) Cook, Inc. Description of the The Kodiak™ Dual Port Coaxial Introducer Kit is intended to introduce Device:… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has a recall.
- 3 other devices also cite its predicate K171999.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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) | — |
What is it indicated for?
The Kodiak™ Dual Port Coaxial Introducer Kit is indicated to introduce therapeutic or diagnostic devices into the vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230631: Kodiak™ Dual Port Coaxial Introducer Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230631
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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