510(k) · Cleared
ClearedInner-Lock 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 Aug 4, 2005 as substantially equivalent to K022170 (Rex Medical, 2003) and 1 other predicate after a 62-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Aug 4, 2005
- Review
- 62 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K954234 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 4 generations backK984260 Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath &…Terumo Medical Corp. · 1999
- 3 generations backK022170 Inner-Lock Locking Introducer SheathsRex Medical · 2003
- 2 generations backK032569 Short Introducer SheathRex Medical · 2003
- 1 generation backK042399 Modification to Short Introducer SheathRex Medical, L.P. · 2004
- This deviceK051468 Inner-Lock Introducer SheathRex Medical · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −4 | K984260 | Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath & Dilator) | Terumo Medical Corp. | 1999 | — |
| −3 | K022170 | Inner-Lock Locking Introducer Sheaths | Rex Medical | 2003 | — |
| −2 | K032569 | Short Introducer Sheath | Rex Medical | 2003 | — |
| −1 | K042399 | Modification to Short Introducer Sheath | Rex Medical, L.P. | 2004 | — |
| 0 (this device) | K051468 | Inner-Lock Introducer Sheath | Rex Medical | 2005 | — |
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 |
|---|---|---|---|
| * | K022170 | Inner-Lock Locking Introducer SheathsSummary page 1…Contact: Denise Flamer Development Engineer 2. Name of the Device: Inner-Lock Introducer Sheath 3. Predicate Device Information: K022170, Rex Medical Inner-Lock Introducer Sheath K042399, Rex Medical Short Introducer Sheath… | 2003 |
| * | K042399 | Modification to Short Introducer SheathSummary page 1…ineer 2. Name of the Device: Inner-Lock Introducer Sheath 3. Predicate Device Information: K022170, Rex Medical Inner-Lock Introducer Sheath K042399, Rex Medical Short Introducer Sheath Page 1 of 3… | 2004 |
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 10 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- None of the 5 ancestors has a recall.
- 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 Inner-Lock Introducer Sheath is 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 sheath 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/K051468 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051468: Inner-Lock Introducer Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051468
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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