510(k) · Cleared
ClearedIntri24 Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inari Medical, Inc. · DYB Introducer, Catheter
Cleared on Apr 1, 2022 as substantially equivalent to K121234 (W. L. Gore & Associates, Inc., 2012) after a 242-day review. Its family tree reaches back 4 generations to 2003. 5 later devices descend from it.
- Decided
- Apr 1, 2022
- Review
- 242 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K032073 (2003). 5 ancestors in all, the oldest K013282 (2001). 5 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK032073 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2003
- 3 generations backK082356 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2008
- 2 generations backK093791 Gore Dryseal SheathW. L. Gore & Associates, Inc. · 2010
- 1 generation backK121234 Gore (R) Dryseal Sheath with Hydrophilic CoatingW. L. Gore & Associates, Inc. · 2012
- This deviceK212392 Intri24 SheathInari Medical, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK230331 Protrieve SheathInari Medical, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK233646 Intri24 Introducer Sheath (52-101)Inari Medical, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK252508 Intri26 Introducer SheathInari Medical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK253323 Protrieve SheathInari Medical · 2025
- Descendant · 2 generations on · 0 of its ownK233815 ClotTriever SheathInari Medical, Inc. · 2023
Most influential descendants
Showing 5 of 5 · See all- K230331Protrieve SheathInari Medical, Inc. · 2023 · cites it directly2descendants
- K233646Intri24 Introducer Sheath (52-101)Inari Medical, Inc. · 2023 · cites it directly1descendant
- K252508Intri26 Introducer SheathInari Medical, Inc. · 2025 · 2 generations on0descendants
- K253323Protrieve SheathInari Medical · 2025 · 2 generations on0descendants
- K233815ClotTriever SheathInari Medical, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K032073 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | 2003 | — |
| −3 | K082356 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | 2008 | — |
| −2 | K093791 | Gore Dryseal Sheath | W. L. Gore & Associates, Inc. | 2010 | — |
| −1 | K121234 | Gore (R) Dryseal Sheath with Hydrophilic Coating | W. L. Gore & Associates, Inc. | 2012 | — |
| 0 (this device) | K212392 | Intri24 Sheath | Inari Medical, Inc. | 2022 | — |
| +1 | K230331 | Protrieve Sheath | Inari Medical, Inc. | 2023 | — |
| +1 | K233646 | Intri24 Introducer Sheath (52-101) | Inari Medical, Inc. | 2023 | — |
| +2 | K252508 | Intri26 Introducer Sheath | Inari Medical, Inc. | 2025 | — |
| +2 | K253323 | Protrieve Sheath | Inari Medical | 2025 | — |
| +2 | K233815 | ClotTriever Sheath | Inari Medical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K121234 | Gore (R) Dryseal Sheath with Hydrophilic CoatingSummary page 4…Classification 21 CFR 870.1340 number Product code DYB Regulatory class II Predicate device W.L. Gore DrySeal Sheath with Hydrophilic Coating (K121234) This product has not been subject to a design-related recall. Reference device ClotTriever Thrombecto… | 2012 |
| † | K180329 | ClotTriever Thrombectomy System | 2018 |
What descends from it? (5)
2 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 19 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K230331 (Inari Medical, Inc., 2023) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K121234.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Intri24 Sheath is indicated to provide a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212392: Intri24 Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212392
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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