510(k) · Cleared

Cleared

Acumen Sheath, Model TTW7807

K042376510(k) TraditionalCleared Oct 26, 200455-day reviewClass II21 CFR 870.1340

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

Acumen Medical, Inc. · DYB Introducer, Catheter

Cleared on Oct 26, 2004 as substantially equivalent to K003731 (Thomas Medical Products, Inc., 2001) after a 55-day review. Its family tree reaches back 1 generation to 2001. 5 later devices descend from it.

Decided: Oct 26, 2004
Review: 55 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003731 (2001). 5 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK003731 Safesheath MSP Introducer Sheath Kit with Integral Hemostasis ValveThomas Medical Products, Inc. · 2001 · Recalled
This deviceK042376 Acumen Sheath, Model TTW7807Acumen Medical, Inc. · 2004
Descendant · cites it directly · 4 of its ownK050015 Modified Acumen Sheath, Model TTWO767Acumen Medical, Inc. · 2005
Descendant · 2 generations on · 3 of its ownK051515 Modified Acumen Sheath, Model TTW 10-65Acumen Medical, Inc. · 2005
Descendant · 3 generations on · 2 of its ownK062145 Modified Acumen Lead Delivery Sheath, Models LDS-10-57…Acumen Medical, Inc. · 2006
Descendant · 4 generations on · 1 of its ownK070197 Acumen Lead Delivery Sheath with Stylet, Models LDS-10-64-Sty and…Acumen Medical, Inc. · 2007
Descendant · 5 generations on · 0 of its ownK083855 Modified Acumen Lead Delivery Sheath with Stylet, Model…Acumen Medical, Inc. · 2009

Most influential descendants

Showing 5 of 5 · See all

K050015Modified Acumen Sheath, Model TTWO767Acumen Medical, Inc. · 2005 · cites it directly4descendants
K051515Modified Acumen Sheath, Model TTW 10-65Acumen Medical, Inc. · 2005 · 2 generations on3descendants
K062145Modified Acumen Lead Delivery Sheath, Models LDS-10-57, LDS-10-57-90, LDS-10-64 and…Acumen Medical, Inc. · 2006 · 3 generations on2descendants
K070197Acumen Lead Delivery Sheath with Stylet, Models LDS-10-64-Sty and LDS-10-57-StyAcumen Medical, Inc. · 2007 · 4 generations on1descendant
K083855Modified Acumen Lead Delivery Sheath with Stylet, Model: Spirit-10.5-59Acumen Medical, Inc. · 2009 · 5 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003731	Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve	Thomas Medical Products, Inc.	2001	6
0 (this device)	K042376	Acumen Sheath, Model TTW7807	Acumen Medical, Inc.	2004	—
+1	K050015	Modified Acumen Sheath, Model TTWO767	Acumen Medical, Inc.	2005	—
+2	K051515	Modified Acumen Sheath, Model TTW 10-65	Acumen Medical, Inc.	2005	—
+3	K062145	Modified Acumen Lead Delivery Sheath, Models LDS-10-57, LDS-10-57-90…	Acumen Medical, Inc.	2006	—
+4	K070197	Acumen Lead Delivery Sheath with Stylet, Models LDS-10-64-Sty and LDS-10-57-Sty	Acumen Medical, Inc.	2007	—
+5	K083855	Modified Acumen Lead Delivery Sheath with Stylet, Model: Spirit-10.5-59	Acumen Medical, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	1	0
2007	1	0
2009	1	0

FIG. 1 — Lineage of K042376, 2001–2009Source: 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 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K003731	Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve Summary page 1 …indicated for the introduction of various types of pacing or defibrillator leads and catheters. Predicate Devices SafeSheath Coronary Sinus Guide K003731 Manufactured by Pressure Products, Inc/Thomas Medical Products Inc. Device Description The Acumen Sheath is a single-use percuta…	Thomas Medical Products, Inc.	2001	6

Also cleared against K003731: 8 other devices →

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K050015	Modified Acumen Sheath, Model TTWO767	Acumen Medical, Inc.	2005	4

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 a recall.
Of its descendants, K050015 (Acumen Medical, Inc., 2005) has gone furthest, with 4 descendants of its own.
8 other devices also cite its predicate K003731.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DYB

16in 2025

2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007high 156 (2018) · low 37 (2008)2026

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

Recalls per year · DYB

3in 2025

2007high 45 (2016) · low 1 (2018)2026

Class I (48 since 2007) Class II/III not classified

Adverse event reports per year · DYB

4,539in 2025

2007high 4,539 (2025) · low 316 (2007)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 Acumen Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042376 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042376: Acumen Sheath, Model TTW7807.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042376

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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