510(k) · Cleared
Recalled · Class II · 2014Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer with Side Port
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Galt Medical · DYB Introducer, Catheter
Cleared on Apr 12, 2012 as substantially equivalent to K000313 (Xentek Medical, Inc., 2000) and 1 other predicate after a 237-day review. Its family tree reaches back 2 generations to 2000. 11 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 12, 2012
- Review
- 237 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000313 (2000). 11 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK000313 Tearaway Introducer SheathXentek Medical, Inc. · 2000 · Recalled
- 1 generation backK043525 Catheter IntroducerGalt Medical Corp. · 2005 · Recalled
- This deviceK112398 Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway…Galt Medical · 2012
- Descendant · cites it directly · 5 of its ownK123430 Microslider Tearaway Introducer SetGalt Medical Corp. · 2013
- Descendant · 2 generations on · 4 of its ownK153533 Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerGalt Medical Corp. · 2016 · Recalled
- Descendant · cites it directly · 3 of its ownK152528 Attachable Cath Lab Hemostasis ValveGalt Medical Corp. · 2015
- Descendant · 2 generations on · 1 of its ownK182660 GaltTWSGalt Medical Corp. · 2019
- Descendant · 3 generations on · 1 of its ownK170020 Peel-Away Introducer SetCook Incorporated · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K123430Microslider Tearaway Introducer SetGalt Medical Corp. · 2013 · cites it directly5descendants
- K153533Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerGalt Medical Corp. · 2016 · 2 generations on4descendants
- K152528Attachable Cath Lab Hemostasis ValveGalt Medical Corp. · 2015 · cites it directly3descendants
- K182660GaltTWSGalt Medical Corp. · 2019 · 2 generations on1descendant
- K170020Peel-Away Introducer SetCook Incorporated · 2017 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000313 | Tearaway Introducer Sheath | Xentek Medical, Inc. | 2000 | 1 |
| −1 | K043525 | Catheter Introducer | Galt Medical Corp. | 2005 | 3 |
| 0 (this device) | K112398 | Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer… | Galt Medical | 2012 | — |
| +1 | K123430 | Microslider Tearaway Introducer Set | Galt Medical Corp. | 2013 | — |
| +2 | K153533 | Tearaway Introducer Sheath, MicroSlide Tearaway Introducer | Galt Medical Corp. | 2016 | 2 |
| +1 | K152528 | Attachable Cath Lab Hemostasis Valve | Galt Medical Corp. | 2015 | — |
| +2 | K182660 | GaltTWS | Galt Medical Corp. | 2019 | — |
| +3 | K170020 | Peel-Away Introducer Set | Cook Incorporated | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K000313 | Tearaway Introducer SheathSummary page 1…Catheter Introducer (DYB), 21 CFR 870.1340 Device Classification: Class 11(Cardiovascular) Predicate Devices: Tearaway Introducer Sheath, K000313 Catheter Introducer, K043525 Manufacturer: Gait Medical… | 2000 |
| * | K043525 | Catheter IntroducerSummary page 1…fication: Class 11(Cardiovascular) Predicate Devices: Tearaway Introducer Sheath, K000313 Catheter Introducer, K043525 Manufacturer: Gait Medical 2220 Merritt Drive… | 2005 |
What descends from it? (11)
See all 113 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 |
|---|---|---|---|---|
| Jul 25, 2014 | Class II | Z-2588-2014 | Nonconforming Material/Component | The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient. |
| Jul 25, 2014 | Class II | Z-2589-2014 | Nonconforming Material/Component | The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K123430 (Galt Medical Corp., 2013) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K000313.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Introducer System is intended for use in percutaneous procedures to introduce
catheters and other intravascular devices into the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112398: Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer with Side Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112398
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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