510(k) Report

510(k) · Cleared

Cleared

Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-10, BLS-9, BLS-7

K080500510(k) SpecialCleared Mar 13, 200817-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 Mar 13, 2008 as substantially equivalent to K053400 (Acumen Medical, Inc., 2006) and 1 other predicate after a 17-day review. Its family tree reaches back 5 generations to 1989. 9 later devices descend from it.

Decided
Mar 13, 2008
Review
17 days
Class
Class II
Product code
DYB
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K893658 (1989). 33 ancestors in all, the oldest K770977 (1977). 9 later devices descend from it, 1 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 ancestor2010: 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 · 2001K053400 · Acumen Single-Lumen Delivery Sheath · Acumen Medical, Inc. · 2006K070396 · Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-8-45, BLS-7-45, BLS-6-45 · Acumen Medical, Inc. · 200719801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors3 generations back: 5 other ancestors4 generations back: 21 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K070396 · Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-8-45, BLS-7-45, BLS-6-45 · Acumen Medical, Inc. · 2007K053400 · Acumen Single-Lumen Delivery Sheath · Acumen Medical, Inc. · 2006K012130 · Attain LDS 6216 Left-Heart Delivery System · Medtronic Vascular · 2001K965167 · Percutaneous Venous Introducer 10264 · Medamicus, Inc. · 1997K893658 · Percutaneous Introducer · Medamicus, Inc. · 1989−50+5
  1. Root · 5 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
  2. 4 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
  3. 3 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
  4. 2 generations backK053400 Acumen Single-Lumen Delivery SheathAcumen Medical, Inc. · 2006
  5. 1 generation backK070396 Modification to: Acumen Single-Lumen Delivery Sheath, Models…Acumen Medical, Inc. · 2007
  6. This deviceK080500 Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-10…Acumen Medical, Inc. · 2008
  7. Descendant · cites it directly · 8 of its ownK101885 Medtronic C315 Delivery CatheterMedtronic, Inc. · 2010 · Recalled
  8. Descendant · 2 generations on · 5 of its ownK190475 Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter…Centerpoint Systems · 2019
  9. Descendant · 3 generations on · 3 of its ownK230363 CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC · 2023
  10. Descendant · 4 generations on · 1 of its ownK250828 CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2025
  11. Descendant · 2 generations on · 1 of its ownK192712 Attain Select II + SureValve delivery catheter system, Attain…Medtronic, Inc. · 2020

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2010: 12019: 12020: 12022: 12023: 12025: 32026: 1
2010high 3 (2025) · low 0 (2011)2026

Most influential descendants

Showing 5 of 9 · See all
  • K101885Medtronic C315 Delivery CatheterMedtronic, Inc. · 2010 · cites it directly8descendants
  • K190475Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery…Centerpoint Systems · 2019 · 2 generations on5descendants
  • K230363CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC · 2023 · 3 generations on3descendants
  • K250828CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2025 · 4 generations on1descendant
  • K192712Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left…Medtronic, Inc. · 2020 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K893658Percutaneous IntroducerMedamicus, Inc.1989—
−4K965167Percutaneous Venous Introducer 10264Medamicus, Inc.1997—
−3K012130Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular2001—
−2K053400Acumen Single-Lumen Delivery SheathAcumen Medical, Inc.2006—
−1K070396Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-8-45…Acumen Medical, Inc.2007—
0 (this device)K080500Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-10, BLS-9…Acumen Medical, Inc.2008—
+1K101885Medtronic C315 Delivery CatheterMedtronic, Inc.20101
+2K190475Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3…Centerpoint Systems2019—
+3K230363CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC2023—
+4K250828CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC2025—
+2K192712Attain Select II + SureValve delivery catheter system, Attain Command +…Medtronic, Inc.2020—

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
201010
201910
202010
202210
202310
202530
202610
FIG. 1 — Lineage of K080500, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K053400Acumen Single-Lumen Delivery Sheath
Summary page 1
…ntroduction of various types of pacing or defibrillator leads and catheters. Predicate Devices Acumen Single-Lumen Delivery Sheath K053400 Manufactured by Acumen Medical, Inc. Modified Acumen Single-Lumen Delivery Sheath K070396…
Acumen Medical, Inc.2006—
*K070396Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-8-45, BLS-7-45, BLS-6-45
Summary page 1
…eath K053400 Manufactured by Acumen Medical, Inc. Modified Acumen Single-Lumen Delivery Sheath K070396 Manufactured by Acumen Medical, Inc. Device Description The Modified Acumen Single-Lumen Delivery Sheath is designed to…
Acumen Medical, Inc.2007—

Also cleared against K053400: 1 other device →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K101885Medtronic C315 Delivery CatheterMedtronic, Inc.20108

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 19 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
  • 5 of the 33 ancestors have a recall of any class.
  • Of its descendants, K101885 (Medtronic, Inc., 2010) has gone furthest, with 8 descendants of its own.
  • 1 other device also cites its predicate K053400.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

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 Modified 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 K053400

1 other device cites the same predicate.

  • K070396Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-8-45, BLS-7-45, BLS-6-45Acumen Medical, Inc. · 2007

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
  • 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
  • K062145Modified Acumen Lead Delivery Sheath, Models LDS-10-57, LDS-10-57-90, LDS-10-64 and LDS-10-64-90Acumen Medical, Inc. · 2006

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/K080500 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080500: Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-10, BLS-9, BLS-7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080500

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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