510(k) · Cleared
ClearedDual Guide Introducer Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · DYB Introducer, Catheter
Cleared on Feb 26, 1990 after a 201-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Feb 26, 1990
- Review
- 201 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK895044 Dual Guide Introducer CatheterCook, Inc. · 1990
- Descendant · cites it directly · 1 of its ownK980504 Emcee Introducer Sheath, Dilator, Obturator, Introducer SetSchneider/Namic · 1998
- Descendant · 2 generations on · 0 of its ownK983039 Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set…Schneider/Namic · 1999
- Descendant · cites it directly · 0 of its ownK960406 Braun Hemostasis IntroducersB.Braun Medical, Inc. · 1996
Most influential descendants
Showing 3 of 3 · See all- K980504Emcee Introducer Sheath, Dilator, Obturator, Introducer SetSchneider/Namic · 1998 · cites it directly1descendant
- K983039Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set Dilator, Emcee Infusion…Schneider/Namic · 1999 · 2 generations on0descendants
- K960406Braun Hemostasis IntroducersB.Braun Medical, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K895044 | Dual Guide Introducer Catheter | Cook, Inc. | 1990 | — |
| +1 | K980504 | Emcee Introducer Sheath, Dilator, Obturator, Introducer Set | Schneider/Namic | 1998 | — |
| +2 | K983039 | Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set Dilator, Emcee… | Schneider/Namic | 1999 | — |
| +1 | K960406 | Braun Hemostasis Introducers | B.Braun Medical, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 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.
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? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K980504 (Schneider/Namic, 1998) has gone furthest, with 1 descendant 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/K895044 · printed Nov 6, 2026
Cite this page
510(k) Report. “K895044: Dual Guide Introducer Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K895044
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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