510(k) · Cleared
Recalled · 2009Crossover
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 3, 2009 as substantially equivalent to K081341 (Thomas Medical Products, Inc., 2008) after a 90-day review. Its family tree reaches back 4 generations to 1993. It has been recalled 2 times.
- Decided
- Feb 3, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K924607 (1993). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
- 3 generations backK012812 Carotid Guiding SheathTerumo Medical Corp. · 2001 · Recalled
- 2 generations backK051601 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2005
- 1 generation backK081341 Reinforced Catheter Introducer System (Rcis)Thomas Medical Products, Inc. · 2008
- This deviceK083269 CrossoverThomas Medical Products, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924607 | Arrow Fischell Kink Resist Percut Sheath Intro Set | Arrow Intl., Inc. | 1993 | 3 |
| −3 | K012812 | Carotid Guiding Sheath | Terumo Medical Corp. | 2001 | 1 |
| −2 | K051601 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2005 | — |
| −1 | K081341 | Reinforced Catheter Introducer System (Rcis) | Thomas Medical Products, Inc. | 2008 | — |
| 0 (this device) | K083269 | Crossover | Thomas Medical Products, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | K081341 | Reinforced Catheter Introducer System (Rcis)Summary page 1…C. Legally marketed device to which equivalence is claimed: Thomas Medical Products, Inc., Reinforced Catheter Introducer System - k08 1341 D. Description of the device: The RCIS consists of a 5-7F spiral reinforced… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 21, 2009 | Not classified | Z-0120-2010 | Component design/selection | Sheath may break or fracture which may cause vessel damage or require surgical intervention to retrieve catheter pieces. |
| Oct 15, 2009 | Not classified | Z-0087-2010 | Component design/selection | Cordis has received complaints of stretching or fracture of the sheath shaft during use. |
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 3.7 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 2 other devices also cite its predicate K081341.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 CSI is indicated for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083269 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083269: Crossover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083269
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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