510(k) · Cleared
ClearedShort Introducer Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rex Medical · DYB Introducer, Catheter
Cleared on Sep 16, 2003 as substantially equivalent to K022170 (Rex Medical, 2003) after a 27-day review. Its family tree reaches back 3 generations to 1995. 15 later devices descend from it.
- Decided
- Sep 16, 2003
- Review
- 27 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954234 (1995). 15 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 2 generations backK984260 Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath &…Terumo Medical Corp. · 1999
- 1 generation backK022170 Inner-Lock Locking Introducer SheathsRex Medical · 2003
- This deviceK032569 Short Introducer SheathRex Medical · 2003
- Descendant · cites it directly · 12 of its ownK033793 Cleaner II Rotational Thrombectomy SystemRex Medical · 2003
- Descendant · cites it directly · 11 of its ownK040252 Cleaner Rotational Thrombectomy System KitRex Medical · 2004
- Descendant · 2 generations on · 10 of its ownK060904 Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2006
- Descendant · 3 generations on · 9 of its ownK091029 Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X…Rex Medical · 2010
- Descendant · 3 generations on · 8 of its ownK120346 Cleaner Rotational Thrombectomy SystemRex Medical · 2012
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K033793Cleaner II Rotational Thrombectomy SystemRex Medical · 2003 · cites it directly12descendants
- K040252Cleaner Rotational Thrombectomy System KitRex Medical · 2004 · cites it directly11descendants
- K060904Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2006 · 2 generations on10descendants
- K091029Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM)Rex Medical · 2010 · 3 generations on9descendants
- K120346Cleaner Rotational Thrombectomy SystemRex Medical · 2012 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −2 | K984260 | Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath & Dilator) | Terumo Medical Corp. | 1999 | — |
| −1 | K022170 | Inner-Lock Locking Introducer Sheaths | Rex Medical | 2003 | — |
| 0 (this device) | K032569 | Short Introducer Sheath | Rex Medical | 2003 | — |
| +1 | K033793 | Cleaner II Rotational Thrombectomy System | Rex Medical | 2003 | — |
| +1 | K040252 | Cleaner Rotational Thrombectomy System Kit | Rex Medical | 2004 | — |
| +2 | K060904 | Cleaner Rotational Thrombectomy System | Rex Medical, L.P. | 2006 | — |
| +3 | K091029 | Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM) | Rex Medical | 2010 | — |
| +3 | K120346 | Cleaner Rotational Thrombectomy System | Rex Medical | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K022170 | Inner-Lock Locking Introducer SheathsSummary page 1…Contact: Mr. Michael Paris Catheter Engineer 2. Name of the Device: Short Introducer Sheaths 3. Predicate Device Information: K#022170, Rex Medical Inner-Lock Locking Introducer Sheath, Rex Medical 4. Device Description: The Rex Medical Short Introducer… | 2003 |
What descends from it? (15)
See all 153 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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K033793 (Rex Medical, 2003) has gone furthest, with 12 descendants of its own.
- 3 other devices also cite its predicate K022170.
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 Short Introducer Sheaths are used to facilitate placing a catheter through the skin into a graft. The dilator is an accessory device which is used by placing it into the sheaths to create an occlusion and further provide support to the wall of the indwelling system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032569 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032569: Short Introducer Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032569
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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