510(k) · Cleared
ClearedTFX Medical Introducer Assembly
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tfx Medical, Inc. · DYB Introducer, Catheter
Cleared on Mar 24, 2000 after a 183-day review. The FDA summary names its predicate without a number. 20 later devices descend from it.
- Decided
- Mar 24, 2000
- Review
- 183 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 4 citing it directly.
- This deviceK993191 TFX Medical Introducer AssemblyTfx Medical, Inc. · 2000
- Descendant · cites it directly · 16 of its ownK022513 Medcomp Vascu-Sheath Introducer SetMedcomp · 2002
- Descendant · cites it directly · 14 of its ownK053092 Medcomp Vascu-Sheath IIMedcomp · 2006
- Descendant · 2 generations on · 12 of its ownK090394 Valved Tearway IntroducerMedcomp · 2009
- Descendant · 3 generations on · 4 of its ownK122422 Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx…Care Fusion · 2012
- Descendant · 4 generations on · 2 of its ownK160437 PleurX Peritoneal Catheter SystemCare Fusion · 2016
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K022513Medcomp Vascu-Sheath Introducer SetMedcomp · 2002 · cites it directly16descendants
- K053092Medcomp Vascu-Sheath IIMedcomp · 2006 · cites it directly14descendants
- K090394Valved Tearway IntroducerMedcomp · 2009 · 2 generations on12descendants
- K122422Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable…Care Fusion · 2012 · 3 generations on4descendants
- K160437PleurX Peritoneal Catheter SystemCare Fusion · 2016 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993191 | TFX Medical Introducer Assembly | Tfx Medical, Inc. | 2000 | — |
| +1 | K022513 | Medcomp Vascu-Sheath Introducer Set | Medcomp | 2002 | — |
| +1 | K053092 | Medcomp Vascu-Sheath II | Medcomp | 2006 | — |
| +2 | K090394 | Valved Tearway Introducer | Medcomp | 2009 | — |
| +3 | K122422 | Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved… | Care Fusion | 2012 | — |
| +4 | K160437 | PleurX Peritoneal Catheter System | Care Fusion | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2006 | 3 | 0 |
| 2009 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | — | Burron Tear-Away Sheath Introducers Named without a submission number | |
| * | — | Daig Corporation introducer Set Named without a submission number |
What descends from it? (20)
See all 204 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, K022513 (Medcomp, 2002) has gone furthest, with 16 descendants 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 TFX Medical Introducer Assembly will be used to provide access to the venous system for device entry, when used in conjunction with additional percutaneous entry devices.
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/K993191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993191: TFX Medical Introducer Assembly.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993191
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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