510(k) · Cleared
Recalled · Class II · 2023Tearaway Introducer Sheath, MicroSlide Tearaway Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Galt Medical Corp. · DYB Introducer, Catheter
Cleared on Jul 5, 2016 as substantially equivalent to K000313 (Xentek Medical, Inc., 2000) and 1 other predicate after a 209-day review. Its family tree reaches back 4 generations to 2000. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 5, 2016
- Review
- 209 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 4 generations to K000313 (2000). 7 ancestors in all, the oldest K954234 (1995). 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK000313 Tearaway Introducer SheathXentek Medical, Inc. · 2000 · Recalled
- 3 generations backK043525 Catheter IntroducerGalt Medical Corp. · 2005 · Recalled
- 2 generations backK112398 Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway…Galt Medical · 2012 · Recalled
- 1 generation backK123430 Microslider Tearaway Introducer SetGalt Medical Corp. · 2013
- This deviceK153533 Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerGalt Medical Corp. · 2016
- Descendant · cites it directly · 1 of its ownK170020 Peel-Away Introducer SetCook Incorporated · 2017
- Descendant · cites it directly · 0 of its ownK261950 Health Line Tearaway IntroducerHealth Line International Corporation · 2026
- Descendant · cites it directly · 0 of its ownK254236 Peel-Away Introducer SheathVascuTech Medical, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK173685 Peel-Away Introducer SetCook Incorporated · 2017
Most influential descendants
Showing 4 of 4 · See all- K170020Peel-Away Introducer SetCook Incorporated · 2017 · cites it directly1descendant
- K261950Health Line Tearaway IntroducerHealth Line International Corporation · 2026 · cites it directly0descendants
- K254236Peel-Away Introducer SheathVascuTech Medical, LLC · 2026 · cites it directly0descendants
- K173685Peel-Away Introducer SetCook Incorporated · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000313 | Tearaway Introducer Sheath | Xentek Medical, Inc. | 2000 | 1 |
| −3 | K043525 | Catheter Introducer | Galt Medical Corp. | 2005 | 3 |
| −2 | K112398 | Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer… | Galt Medical | 2012 | 2 |
| −1 | K123430 | Microslider Tearaway Introducer Set | Galt Medical Corp. | 2013 | — |
| 0 (this device) | K153533 | Tearaway Introducer Sheath, MicroSlide Tearaway Introducer | Galt Medical Corp. | 2016 | — |
| +1 | K170020 | Peel-Away Introducer Set | Cook Incorporated | 2017 | — |
| +1 | K261950 | Health Line Tearaway Introducer | Health Line International Corporation | 2026 | — |
| +1 | K254236 | Peel-Away Introducer Sheath | VascuTech Medical, LLC | 2026 | — |
| +2 | K173685 | Peel-Away Introducer Set | Cook Incorporated | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 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 4…Introducer (DYB), 21 CFR 870.1340 Device Classification: Class II (Cardiovascular) Predicate Device: Tearaway Introducer Sheath (K000313) MicroSlide™ Tearaway Introducer (K123430) Manufacturer: Galt Medical… | 2000 |
| * | K123430 | Microslider Tearaway Introducer SetSummary page 4…assification: Class II (Cardiovascular) Predicate Device: Tearaway Introducer Sheath (K000313) MicroSlide™ Tearaway Introducer (K123430) Manufacturer: Galt Medical 2220 Merritt Drive Garland, TX 75… | 2013 |
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 |
|---|---|---|---|---|
| May 8, 2023 | Class II | Z-1969-2023 | Process design | Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the… |
| May 8, 2023 | Class II | Z-1968-2023 | Process design | Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K170020 (Cook Incorporated, 2017) has gone furthest, with 1 descendant 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. 2016, 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?
Tearaway introducer sheath: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters and pacing leads, into the vasculature.
MicroSlide™ Tearaway introducer: These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153533 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153533: Tearaway Introducer Sheath, MicroSlide Tearaway Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153533
Report an extraction error
Are you the manufacturer?
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