510(k) · Cleared
ClearedInner-Lock Locking Introducer Sheaths
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rex Medical · DYB Introducer, Catheter
Cleared on Jan 21, 2003 as substantially equivalent to K954234 (Terumo Medical Corp., 1995) and 1 other predicate after a 202-day review. Its family tree reaches back 2 generations to 1995. 16 later devices descend from it.
- Decided
- Jan 21, 2003
- Review
- 202 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K954234 (1995). 16 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 1 generation backK984260 Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath &…Terumo Medical Corp. · 1999
- This deviceK022170 Inner-Lock Locking Introducer SheathsRex Medical · 2003
- Descendant · cites it directly · 15 of its ownK032569 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
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K032569Short Introducer SheathRex Medical · 2003 · cites it directly15descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −1 | K984260 | Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath & Dilator) | Terumo Medical Corp. | 1999 | — |
| 0 (this device) | K022170 | Inner-Lock Locking Introducer Sheaths | Rex Medical | 2003 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 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? (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 |
|---|---|---|---|
| * | K954234 | Radifocus Introducer II KitSummary page 1…Date Summary Prepared: July 1, 2002 2. Name of the Device: Inner-Lock Locking Introducer Sheaths 3. Predicate Device Information: K#954234, K#984260: PINNACLETMR/O or RADIFOCUSB Introducer R/O device, Terumo Medical Corporation, Elkton, MD 4. Device Descri… | 1995 |
| * | K984260 | Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath & Dilator)Summary page 1…Summary Prepared: July 1, 2002 2. Name of the Device: Inner-Lock Locking Introducer Sheaths 3. Predicate Device Information: K#954234, K#984260: PINNACLETMR/O or RADIFOCUSB Introducer R/O device, Terumo Medical Corporation, Elkton, MD 4. Device Description:… | 1999 |
What descends from it? (16)
See all 164 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 4.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K032569 (Rex Medical, 2003) has gone furthest, with 15 descendants of its own.
- 4 other devices also cite its predicate K954234.
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 Locking introducer Sheaths are used to facilitate placing a catheter through the skin into a graft. The Inner-Lock 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 sheath.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022170 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022170: Inner-Lock Locking Introducer Sheaths.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022170
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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