510(k) Report

510(k) · Cleared

Cleared

Acumen Single-Lumen Delivery Sheath

K053400510(k) TraditionalCleared Jun 19, 2006195-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 Jun 19, 2006 as substantially equivalent to K003731 (Thomas Medical Products, Inc., 2001) and 2 other predicates after a 195-day review. Its family tree reaches back 3 generations to 1989. 11 later devices descend from it.

Decided
Jun 19, 2006
Review
195 days
Class
Class II
Product code
DYB
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K893658 (1989). 31 ancestors in all, the oldest K770977 (1977). 11 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors1999: 1 other ancestor1996: 1 other ancestor1995: 3 other ancestors1990: 5 other ancestors1994: 3 other ancestors1993: 1 other ancestor1992: 3 other ancestors1991: 1 other ancestor1988: 1 other ancestor1987: 3 other ancestors1986: 1 other ancestor1985: 2 other ancestors1977: 1 other ancestor2008: 1 descendant cleared2007: 1 descendant cleared2010: 1 descendant cleared2019: 1 descendant cleared2020: 1 descendant cleared2025: 3 descendants cleared2023: 1 descendant cleared2022: 1 descendant cleared2026: 1 descendant clearedK893658 · Percutaneous Introducer · Medamicus, Inc. · 1989K965167 · Percutaneous Venous Introducer 10264 · Medamicus, Inc. · 1997K012130 · Attain LDS 6216 Left-Heart Delivery System · Medtronic Vascular · 200119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 5 other ancestors3 generations back: 21 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 3 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant K012130 · Attain LDS 6216 Left-Heart Delivery System · Medtronic Vascular · 2001K965167 · Percutaneous Venous Introducer 10264 · Medamicus, Inc. · 1997K893658 · Percutaneous Introducer · Medamicus, Inc. · 19890+5
  1. Root · 3 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
  2. 2 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
  3. 1 generation backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
  4. This deviceK053400 Acumen Single-Lumen Delivery SheathAcumen Medical, Inc. · 2006
  5. Descendant · cites it directly · 10 of its ownK070396 Modification to: Acumen Single-Lumen Delivery Sheath, Models…Acumen Medical, Inc. · 2007
  6. Descendant · cites it directly · 9 of its ownK080500 Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-10…Acumen Medical, Inc. · 2008
  7. Descendant · 2 generations on · 8 of its ownK101885 Medtronic C315 Delivery CatheterMedtronic, Inc. · 2010 · Recalled
  8. Descendant · 3 generations on · 5 of its ownK190475 Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter…Centerpoint Systems · 2019
  9. Descendant · 4 generations on · 3 of its ownK230363 CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC · 2023

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12010: 12019: 12020: 12022: 12023: 12025: 32026: 1
2007high 3 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 11 · See all
  • K070396Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-8-45, BLS-7-45, BLS-6-45Acumen Medical, Inc. · 2007 · cites it directly10descendants
  • K080500Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-10, BLS-9, BLS-7Acumen Medical, Inc. · 2008 · cites it directly9descendants
  • K101885Medtronic C315 Delivery CatheterMedtronic, Inc. · 2010 · 2 generations on8descendants
  • K190475Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery…Centerpoint Systems · 2019 · 3 generations on5descendants
  • K230363CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC · 2023 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K893658Percutaneous IntroducerMedamicus, Inc.1989—
−2K965167Percutaneous Venous Introducer 10264Medamicus, Inc.1997—
−1K012130Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular2001—
0 (this device)K053400Acumen Single-Lumen Delivery SheathAcumen Medical, Inc.2006—
+1K070396Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-8-45…Acumen Medical, Inc.2007—
+1K080500Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-10, BLS-9…Acumen Medical, Inc.2008—
+2K101885Medtronic C315 Delivery CatheterMedtronic, Inc.20101
+3K190475Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3…Centerpoint Systems2019—
+4K230363CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197710
198520
198610
198730
198810
199050
199110
199230
199310
199430
199530
199610
199910
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
201010
201910
202010
202210
202310
202530
202610
FIG. 1 — Lineage of K053400, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K003731Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve
Summary page 1
…introduction of various types of pacing or defibrillator leads and catheters. Predicate Devices SafeSheath K00373 1 Manufactured by Thomas Medical Products Attain Access 6216 Left Heart Delivery System K012130…
Thomas Medical Products, Inc.20016
*K012130Attain LDS 6216 Left-Heart Delivery System
Summary page 1
…K00373 1 Manufactured by Thomas Medical Products Attain Access 6216 Left Heart Delivery System K012130 Manufactured by Medtronic, Inc. Attain Access 6218 Left Heart Delivery System K012083…
Medtronic Vascular2001—
*K012083Attain Access 6218 Left-Heart Delivery System, Model 6218
Summary page 1
…Heart Delivery System K012130 Manufactured by Medtronic, Inc. Attain Access 6218 Left Heart Delivery System K012083 Manufactured by Medtronic, Inc. The Acumen Single-Lumen Delivery Sheath is designed to aid in the introduction of vari…
Medtronic Vascular2001—

Also cleared against K003731: 8 other devices →

What descends from it? (11)

See all 11

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070396Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-8-45, BLS-7-45, BLS-6-45Acumen Medical, Inc.200710
K080500Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-10, BLS-9, BLS-7Acumen Medical, Inc.20089

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 17 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
  • 5 of the 31 ancestors have a recall of any class.
  • Of its descendants, K070396 (Acumen Medical, Inc., 2007) has gone furthest, with 10 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

2007: 122008: 172009: 142010: 182011: 172012: 222013: 262014: 302015: 172016: 192017: 242018: 192019: 182020: 92021: 122022: 132023: 152024: 182025: 162026 (partial year): 17
2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007: 95 days median2008: 37 days median2009: 52 days median2010: 123 days median2011: 100 days median2012: 128 days median2013: 118 days median2014: 122 days median2015: 129 days median2016: 95 days median2017: 70 days median2018: 156 days median2019: 47 days median2020: 49 days median2021: 78 days median2022: 143 days median2023: 55 days median2024: 56 days median2025: 63 days median2026 (partial year): 59 days median
2007high 156 (2018) · low 37 (2008)2026

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

Recalls per year · DYB

3in 2025

2007: 152008: 92009: 252010: 182011: 42012: 32013: 5, 1 Class I2014: 22015: 2, 1 Class I2016: 45, 3 Class I2017: 22, 1 Class I2018: 12019: 22020: 21, 21 Class I2021: 62022: 22023: 102024: 22025: 32026 (partial year): 23, 21 Class I
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

2007: 3162008: 4232009: 3992010: 4452011: 6282012: 8982013: 7432014: 7802015: 9132016: 1,2342017: 1,6722018: 1,9032019: 2,4502020: 2,4652021: 2,8352022: 4,0842023: 3,7752024: 3,9312025: 4,539
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007129515316
200817379423
2009145225399
20101812318445
2011171004628
2012221283898
2013261185 (1)743
2014301222780
2015171292 (1)913
2016199545 (3)1,234
2017247022 (1)1,672
20181915611,903
2019184722,450
202094921 (21)2,465
2021127862,835
20221314324,084
20231555103,775
2024185623,931
2025166334,539
2026175923 (21)—

What is it indicated for?

The Acumen Single-Lumen Delivery Sheath is intended for the introduction of various types of pacing or defibrillator leads and catheters.

Indications for use as stated in the FDA summary.

Also cleared against K003731

8 other devices cite the same predicate.

  • K120158Coronary Sinus Guide and Lateral Vein Introducer KitsThomas Medical Products, Inc. · 20122 recalls
  • K063182Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-XXXEnpath Medical, Inc. · 2006
  • K050808Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc. · 2005
  • K042376Acumen Sheath, Model TTW7807Acumen Medical, Inc. · 2004
  • K023937Cook Vascular Serpenta Coronary Sinus Introducer SystemCook Vascular, Inc. · 2003
  • K01351710600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002

More from Acumen Medical, Inc.

12 FDA decisions under this applicant name. See the company

  • K083855Modified Acumen Lead Delivery Sheath with Stylet, Model: Spirit-10.5-59Acumen Medical, Inc. · 2009
  • K080500Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-10, BLS-9, BLS-7Acumen Medical, Inc. · 2008
  • K070396Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-8-45, BLS-7-45, BLS-6-45Acumen Medical, Inc. · 2007
  • K070051Acumen Insight Endocardial Visualization SystemAcumen Medical, Inc. · 2007
  • K070197Acumen Lead Delivery Sheath with Stylet, Models LDS-10-64-Sty and LDS-10-57-StyAcumen Medical, Inc. · 2007

Recent decisions in DYB

The DYB category page

  • K262674Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd. · 2026
  • K253526NAMIC Dilator and SheathMedline Industries, LP · 2026
  • K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit /…Hartman Medical Group, LLC · 2026
  • K261242SimplGuidePendracare · 2026
  • K261950Health Line Tearaway IntroducerHealth Line International Corporation · 2026

https://510kreport.com/device/K053400 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053400: Acumen Single-Lumen Delivery Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053400

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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