510(k) · Cleared
Recalled · 2011Baxter Hemostasis Valve Introducers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Edwards · DYB Introducer, Catheter
Cleared on Nov 24, 1998 after a 176-day review. The FDA summary names its predicate without a number. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 24, 1998
- Review
- 176 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 3
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK981909 Baxter Hemostasis Valve IntroducersBaxter Edwards · 1998
- Descendant · cites it directly · 1 of its ownK121185 Edwards Percutaneous Sheath IntroducerEdwards Lifesciences, LLC · 2012
- Descendant · cites it directly · 0 of its ownK131627 Catheter Introducer SheathEdwards Lifesciences, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK133296 XCATHAlseal · 2014
- Descendant · cites it directly · 0 of its ownK032962 AC 3 Lumen Central Venous Access Kit with Arrowg+Ard Antimicrobial…Arrow Intl., Inc. · 2003
Most influential descendants
Showing 4 of 4 · See all- K121185Edwards Percutaneous Sheath IntroducerEdwards Lifesciences, LLC · 2012 · cites it directly1descendant
- K131627Catheter Introducer SheathEdwards Lifesciences, LLC · 2014 · cites it directly0descendants
- K133296XCATHAlseal · 2014 · 2 generations on0descendants
- K032962AC 3 Lumen Central Venous Access Kit with Arrowg+Ard Antimicrobial SurfaceArrow Intl., Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981909 | Baxter Hemostasis Valve Introducers | Baxter Edwards | 1998 | — |
| +1 | K121185 | Edwards Percutaneous Sheath Introducer | Edwards Lifesciences, LLC | 2012 | — |
| +1 | K131627 | Catheter Introducer Sheath | Edwards Lifesciences, LLC | 2014 | — |
| +2 | K133296 | XCATH | Alseal | 2014 | — |
| +1 | K032962 | AC 3 Lumen Central Venous Access Kit with Arrowg+Ard Antimicrobial Surface | Arrow Intl., Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 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 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? (3)
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 |
|---|---|---|---|
| * | — | Baxter Healthcare Intro-Flex® Percutaneous Sheath Introducer Named without a submission number | |
| * | — | Cook Critical Care Intro Deuce Hemostasis Valve set Named without a submission number | |
| * | — | Bard Access Systems Peel-Apart Percutaneous Introducer Kit Named without a submission number |
What descends from it? (4)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 15, 2011 | Not classified | Z-2777-2011 | Employee error | Possibility of separation of the introducer sheath from the hub on Coronary Sinus Catheters. |
| Jun 15, 2011 | Not classified | Z-2776-2011 | Employee error | Possibility of separation of the introducer sheath from the hub on Coronary Sinus Catheters. |
| May 11, 2009 | Not classified | Z-1913-2009 | Nonconforming Material/Component | Edwards LifeSciences LLC received several complaints, in which the blue connector of the introducer assembly has broken (fracture/separation) after several hours of use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K121185 (Edwards Lifesciences, LLC, 2012) 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) | — |
What is it indicated for?
The Baxter Healthcare Single Lumen Hemostasis Valve Introducers are indicated for use in patients requiring access of the venous system and to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter).
The Baxter Healthcare Multiple Lumen Access Products are indicated for use in patients requiring access of the venous system, to facilitate catheter insertion (e.g., pulmonary artery or infusion catheter) and central venous pressure monitoring.
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/K981909 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981909: Baxter Hemostasis Valve Introducers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981909
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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