510(k) · Cleared
ClearedModification to Transseptal Introducer Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thomas Medical Products, Inc. · DYB Introducer, Catheter
Cleared on Feb 11, 2002 as substantially equivalent to K932619 (Thomas Medical Products, Inc., 1993) after a 32-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- Feb 11, 2002
- Review
- 32 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K932619 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK932619 Transseptal Introducer SetThomas Medical Products, Inc. · 1993
- This deviceK020090 Modification to Transseptal Introducer SetThomas Medical Products, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK061070 Hansen Medical Transseptal Needle and DilatorHansen Medical, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK082075 Hansen Medical Dilator for Artisan Control CatheterHansen Medical, Inc. · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932619 | Transseptal Introducer Set | Thomas Medical Products, Inc. | 1993 | — |
| 0 (this device) | K020090 | Modification to Transseptal Introducer Set | Thomas Medical Products, Inc. | 2002 | — |
| +1 | K061070 | Hansen Medical Transseptal Needle and Dilator | Hansen Medical, Inc. | 2006 | — |
| +2 | K082075 | Hansen Medical Dilator for Artisan Control Catheter | Hansen Medical, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K932619 | Transseptal Introducer SetSummary page 1…r (21 CFR §870.1250) Transseptal Introducer Set C. Legally marketed device to which equivalence is claimed: Thomas Medical Products, Inc., Transseptal Introducer Set (K932619) D. Description of the device: The Thomas Medical Products Inc. modified Transseptal Introducer Sets are designed to provide a… | 1993 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061070 | Hansen Medical Transseptal Needle and Dilator | 2006 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K061070 (Hansen Medical, Inc., 2006) 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?
For the introduction of various types of cardiovascular catheters into the left side of the heart through the interatrial septum.
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/K020090 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020090: Modification to Transseptal Introducer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020090
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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