510(k) · Cleared
ClearedValved Tearaway Introducer Generation II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Components, Inc. · DYB Introducer, Catheter
Cleared on Jun 3, 2013 as substantially equivalent to K090394 (Medcomp, 2009) after a 154-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Jun 3, 2013
- Review
- 154 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K932323 (1993). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 4 generations backK021004 Valved Peelable IntroducerMedamicus, Inc. · 2002
- 3 generations backK030905 Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2003
- 2 generations backK040150 Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2004
- 1 generation backK090394 Valved Tearway IntroducerMedcomp · 2009
- This deviceK124046 Valved Tearaway Introducer Generation IIMedical Components, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K932323 | Percutaneous Introducer | Medamicus, Inc. | 1993 | — |
| −4 | K021004 | Valved Peelable Introducer | Medamicus, Inc. | 2002 | — |
| −3 | K030905 | Medamicus Flowguard Peelable Introducer | Medamicus, Inc. | 2003 | — |
| −2 | K040150 | Modification to Medamicus Flowguard Peelable Introducer | Medamicus, Inc. | 2004 | — |
| −1 | K090394 | Valved Tearway Introducer | Medcomp | 2009 | — |
| 0 (this device) | K124046 | Valved Tearaway Introducer Generation II | Medical Components, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 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? (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 |
|---|---|---|---|
| * | K090394 | Valved Tearway IntroducerSummary page 1…cation Name: Blood Access device and accessories (a)(2)Xb)(2) C.F.R. Section: Classification Panel: Class: Predicate Devices: Primary: 870.1340 Cardiovascular I, DYB K090394, Valved Tearaway Introducer Generation I, concurrence date September 1, 2009, Class 11 CFR 870.1340 " Device Description: The M… | 2009 |
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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 9 ancestors has a recall.
- 3 other devices also cite its predicate K090394.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Valved Tearaway Introducers are intended to obtain central venous access to facilitate catheter insertion into the central venous system.
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/K124046 · printed Nov 6, 2026
Cite this page
510(k) Report. “K124046: Valved Tearaway Introducer Generation II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K124046
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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