510(k) · Cleared

Cleared

Pruitt Carotid Kit

K103356510(k) SpecialCleared Dec 8, 201022-day reviewClass II21 CFR 870.4450

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

LeMaitre Vascular, Inc. · MJN Catheter, Intravascular Occluding, Temporary

Cleared on Dec 8, 2010 as substantially equivalent to K051067 (LeMaitre Vascular, Inc., 2005) and 1 other predicate after a 22-day review. Its family tree reaches back 4 generations to 1985. 1 of the 15 devices in its family, counting itself, has a Class I recall.

Decided: Dec 8, 2010
Review: 22 days
Class: Class II
Product code: MJN
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K842066 (1985). 14 ancestors in all, the oldest K830863 (1983). No later device cites it as a predicate yet. 1 of the 15 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 4 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
3 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
2 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
1 generation backK040835 Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16Pm Devices, Inc. · 2004
This deviceK103356 Pruitt Carotid KitLeMaitre Vascular, Inc. · 2010

Class I recalls in this family

K963967 Glycar Pericardial Patch2 generations back · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K842066	Peri-Guard Pericardial Patch	Genetic Laboratories, Inc.	1985	—
−3	K961811	Peri-Guard Pericardium	Bio-Vascular, Inc.	1996	—
−2	K983162	Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…	Bio-Vascular, Inc.	1998	2
−1	K040835	Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16	Pm Devices, Inc.	2004	—
0 (this device)	K103356	Pruitt Carotid Kit	LeMaitre Vascular, Inc.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	1	0
1992	2	0
1994	1	0
1996	2	0
1997	1	1
2003	1	0
2004	1	0
2005	1	0

FIG. 1 — Lineage of K103356, 1985–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

1 device in this family has a Class I recall. 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

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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	Applicant	Decided	Recalls
*	K051067	Pruitt F3 Outlying and Inlying Carotid Shunt (with and Without T-Port)	LeMaitre Vascular, Inc.	2005	1
*	K040835	Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16 Summary page 1 …ommon Name: Carotid Kit Classification Name: N/A Predicate Device: Pruitt F3 Carotid Shunt (KOS 1067) Peripatch Biologic Patch (K040835) Device Description: The Pruitt Carotid Kit is a convenience kit composed of Pruitt F3 carotid shunt an…	Pm Devices, Inc.	2004	—

Also cleared against K051067: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K963967Glycar Pericardial PatchGlycar, Inc. · 1997 · 2 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls

What does this lineage say?

The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
3 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
3 other devices also cite its predicate K051067.

How does its category compare?

All MJN devices

MJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · MJN

2in 2025

2007high 5 (2009) · low 0 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MJN

116in 2021

2007high 245 (2015) · low 30 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MJN

1in 2020

2007high 8 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MJN

194in 2025

2007high 224 (2024) · low 25 (2007)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?

For Pruitt F3 Carotid Shunts:

The Pruitt F3 carotid shunts are indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries. The size 8 French Shunt is intended for use on those patients whose vasculature is too small to accommodate a size 9 French Shunt.

For XenoSure Biologic Patch:

The patch is intended for use as a surgical patch material for: cardiac and vascular reconstruction and repair, soft tissue deficiency repair and reinforcing the suture line during general surgical procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103356 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103356: Pruitt Carotid Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103356

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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