510(k) · Cleared
ClearedPruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lemaitre Vascular · MJN Catheter, Intravascular Occluding, Temporary
Cleared on Nov 16, 2018 as substantially equivalent to K051067 (LeMaitre Vascular, Inc., 2005) after a 29-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Nov 16, 2018
- Review
- 29 days
- Class
- Class II
- Product code
- MJN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K960715 (1996). No later device cites it as a predicate yet.
- Root · 3 generations backK960715 Pruitt-Inahara Carotid Shunt 400-40-8F/Inahara-Pruitt Carotid Shunt…Ideas For Medicine, Inc. · 1996
- 2 generations backK043023 Pruitt-Inahara Outlying Carotid Shunt, Models, 2012-49, 2013-49…LeMaitre Vascular, Inc. · 2004
- 1 generation backK051067 Pruitt F3 Outlying and Inlying Carotid Shunt (with and Without T-Port)LeMaitre Vascular, Inc. · 2005 · Recalled
- This deviceK182916 Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr…Lemaitre Vascular · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960715 | Pruitt-Inahara Carotid Shunt 400-40-8F/Inahara-Pruitt Carotid Shunt 500-50-8F | Ideas For Medicine, Inc. | 1996 | — |
| −2 | K043023 | Pruitt-Inahara Outlying Carotid Shunt, Models, 2012-49, 2013-49… | LeMaitre Vascular, Inc. | 2004 | — |
| −1 | K051067 | Pruitt F3 Outlying and Inlying Carotid Shunt (with and Without T-Port) | LeMaitre Vascular, Inc. | 2005 | 1 |
| 0 (this device) | K182916 | Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3… | Lemaitre Vascular | 2018 | — |
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 MJN? 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 MJN device
- #1 K243795 pREBOA-PRO Catheterscore 12.1 · 8 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 |
|---|---|---|---|
| * | K051067 | Pruitt F3 Outlying and Inlying Carotid Shunt (with and Without T-Port)Summary page 4…No prior submissions have been made for the changes detailed in this special 510(k). II. PREDICATE DEVICE Pruitt F3 Carotid Shunt (K051067) This predicate device has not been subject to a design- related recall… | 2005 |
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 22 years and passes through 3 companies; a new generation was cleared every 8.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 3 other devices also cite its predicate K051067.
How does its category compare?
All MJN devicesMJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MJN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MJN
116in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MJN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJN
194in 2025
MAUDE reports naming product code MJN, 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 | 2 | — | 0 | 25 |
| 2008 | 3 | 153 | 2 | 26 |
| 2009 | 5 | 39 | 0 | 25 |
| 2010 | 5 | 30 | 1 | 35 |
| 2011 | 4 | 69 | 1 | 92 |
| 2012 | 2 | — | 0 | 53 |
| 2013 | 4 | 87 | 8 | 76 |
| 2014 | 2 | — | 0 | 100 |
| 2015 | 4 | 245 | 1 | 90 |
| 2016 | 3 | 110 | 2 | 71 |
| 2017 | 3 | 54 | 0 | 157 |
| 2018 | 3 | 63 | 1 | 107 |
| 2019 | 3 | 117 | 0 | 139 |
| 2020 | 4 | 64 | 1 | 157 |
| 2021 | 4 | 116 | 0 | 158 |
| 2022 | 2 | — | 0 | 148 |
| 2023 | 1 | — | 0 | 181 |
| 2024 | 0 | — | 0 | 224 |
| 2025 | 2 | — | 0 | 194 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Pruitt F3 Carotid Shunt is indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182916 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182916: Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182916
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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