510(k) · Cleared

Cleared

Suturing Washer

K052642510(k) TraditionalCleared Jan 17, 2006113-day reviewClass II21 CFR 870.3450

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

First Call, Inc. · MAB Marker, Cardiopulmonary Bypass (Vein Marker)

Cleared on Jan 17, 2006 as substantially equivalent to K864101 (Cook, Inc., 1986) after a 113-day review. Its family tree reaches back 1 generation to 1986.

Decided: Jan 17, 2006
Review: 113 days
Class: Class II
Product code: MAB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K864101 (1986). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK864101 Cook (R) Vein Graft Ring MarkersCook, Inc. · 1986
This deviceK052642 Suturing WasherFirst Call, Inc. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K864101	Cook (R) Vein Graft Ring Markers	Cook, Inc.	1986	—
0 (this device)	K052642	Suturing Washer	First Call, Inc.	2006	—

FIG. 1 — Lineage of K052642, 1986–2006Source: 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.

Planning a device in MAB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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	Applicant	Decided	Recalls
*	K864101	Cook (R) Vein Graft Ring Markers Summary page 1 …s (Vein Marker) CLASSIFICATION: unclassified DEVICE PRODUCT CODE: MAB PREDICATE DEVICE: Cook Vein Giraft Ring Marker, K864101t, Cleared 30 October 1986 DEVICE DESCRIPTION: This 4.5mmn outer diameter suturi…	Cook, Inc.	1986	—

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?

Its one ancestor has no recall.

How does its category compare?

All MAB devices

MAB Marker, Cardiopulmonary Bypass (Vein Marker): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MAB

FDA has decided no MAB device since 2007.

Median 510(k) review, days · MAB

Too few MAB 510(k)s in any year since 2007 to give a median.

Recalls per year · MAB

No recall names MAB since 2007.

Adverse event reports per year · MAB

No MAUDE report names MAB since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

This single use device is for radiological identification of the aortic anastomosis in coronary artery bypass surgery

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052642 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052642: Suturing Washer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052642

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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