510(k) · Cleared
ClearedProtrieve Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inari Medical, Inc. · QEW Peripheral Mechanical Thrombectomy With Aspiration
Cleared on Mar 7, 2023 as substantially equivalent to K212392 (Inari Medical, Inc., 2022) after a 28-day review. Its family tree reaches back 5 generations to 2003. 2 later devices descend from it.
- Decided
- Mar 7, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K032073 (2003). 6 ancestors in all, the oldest K013282 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK032073 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2003
- 4 generations backK082356 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2008
- 3 generations backK093791 Gore Dryseal SheathW. L. Gore & Associates, Inc. · 2010
- 2 generations backK121234 Gore (R) Dryseal Sheath with Hydrophilic CoatingW. L. Gore & Associates, Inc. · 2012
- 1 generation backK212392 Intri24 SheathInari Medical, Inc. · 2022
- This deviceK230331 Protrieve SheathInari Medical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK253323 Protrieve SheathInari Medical · 2025
- Descendant · cites it directly · 0 of its ownK233815 ClotTriever SheathInari Medical, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K032073 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | 2003 | — |
| −4 | K082356 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | 2008 | — |
| −3 | K093791 | Gore Dryseal Sheath | W. L. Gore & Associates, Inc. | 2010 | — |
| −2 | K121234 | Gore (R) Dryseal Sheath with Hydrophilic Coating | W. L. Gore & Associates, Inc. | 2012 | — |
| −1 | K212392 | Intri24 Sheath | Inari Medical, Inc. | 2022 | — |
| 0 (this device) | K230331 | Protrieve Sheath | Inari Medical, Inc. | 2023 | — |
| +1 | K253323 | Protrieve Sheath | Inari Medical | 2025 | — |
| +1 | 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 | 1 | 0 |
| 2025 | 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 QEW? 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 QEW device
- #1 K213402 Triever24, Triever20score 28.6 · 5 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 |
|---|---|---|---|
| * | K212392 | Intri24 SheathSummary page 4…umber 21 CFR 870.5150 Primary product code QEW Secondary product KRA, DYB codes Regulatory class II Predicate device Intri24™ Introducer Sheath (K212392) Reference device Protrieve™ Sheath (K220415) Description The Protrieve Sheath is a sterile, single-use over-t… | 2022 |
| † | K220415 | Protrieve Sheath | 2022 |
What descends from it? (2)
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 20 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K253323 (Inari Medical, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K212392.
How does its category compare?
All QEW devicesQEW Peripheral Mechanical Thrombectomy With Aspiration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QEW
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEW
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEW
7in 2022
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · QEW
207in 2025
MAUDE reports naming product code QEW, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 4 | 88 | 0 | 0 |
| 2016 | 4 | 63 | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 14 | 61 | 0 | 0 |
| 2019 | 8 | 51 | 0 | 33 |
| 2020 | 16 | 105 | 0 | 197 |
| 2021 | 11 | 60 | 0 | 322 |
| 2022 | 12 | 140 | 7 (7) | 125 |
| 2023 | 23 | 102 | 0 | 165 |
| 2024 | 14 | 65 | 0 | 162 |
| 2025 | 14 | 58 | 0 | 207 |
| 2026 | 10 | 74 | 0 | — |
What is it indicated for?
The ClotTriever Thrombectomy System is indicated for:
• The non-surgical removal of thrombi and emboli from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).
The Protrieve Sheath is indicated for use as 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/K230331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230331: Protrieve Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230331
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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