510(k) · Cleared
ClearedModified Acumen Sheath, Model TTW 10-65
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acumen Medical, Inc. · DYB Introducer, Catheter
Cleared on Sep 1, 2005 as substantially equivalent to K050015 (Acumen Medical, Inc., 2005) after an 85-day review. Its family tree reaches back 3 generations to 2001. 3 later devices descend from it.
- Decided
- Sep 1, 2005
- Review
- 85 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003731 (2001). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK003731 Safesheath MSP Introducer Sheath Kit with Integral Hemostasis ValveThomas Medical Products, Inc. · 2001 · Recalled
- 2 generations backK042376 Acumen Sheath, Model TTW7807Acumen Medical, Inc. · 2004
- 1 generation backK050015 Modified Acumen Sheath, Model TTWO767Acumen Medical, Inc. · 2005
- This deviceK051515 Modified Acumen Sheath, Model TTW 10-65Acumen Medical, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK062145 Modified Acumen Lead Delivery Sheath, Models LDS-10-57…Acumen Medical, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK070197 Acumen Lead Delivery Sheath with Stylet, Models LDS-10-64-Sty and…Acumen Medical, Inc. · 2007
- Descendant · 3 generations on · 0 of its ownK083855 Modified Acumen Lead Delivery Sheath with Stylet, Model…Acumen Medical, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See all- K062145Modified Acumen Lead Delivery Sheath, Models LDS-10-57, LDS-10-57-90, LDS-10-64 and…Acumen Medical, Inc. · 2006 · cites it directly2descendants
- K070197Acumen Lead Delivery Sheath with Stylet, Models LDS-10-64-Sty and LDS-10-57-StyAcumen Medical, Inc. · 2007 · 2 generations on1descendant
- K083855Modified Acumen Lead Delivery Sheath with Stylet, Model: Spirit-10.5-59Acumen Medical, Inc. · 2009 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003731 | Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve | Thomas Medical Products, Inc. | 2001 | 6 |
| −2 | K042376 | Acumen Sheath, Model TTW7807 | Acumen Medical, Inc. | 2004 | — |
| −1 | K050015 | Modified Acumen Sheath, Model TTWO767 | Acumen Medical, Inc. | 2005 | — |
| 0 (this device) | K051515 | Modified Acumen Sheath, Model TTW 10-65 | Acumen Medical, Inc. | 2005 | — |
| +1 | K062145 | Modified Acumen Lead Delivery Sheath, Models LDS-10-57, LDS-10-57-90… | Acumen Medical, Inc. | 2006 | — |
| +2 | K070197 | Acumen Lead Delivery Sheath with Stylet, Models LDS-10-64-Sty and LDS-10-57-Sty | Acumen Medical, Inc. | 2007 | — |
| +3 | 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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K050015 | Modified Acumen Sheath, Model TTWO767Summary page 1…icated for the introduction of various types of pacing or defibrillator leads and catheters. Predicate Devices Acumen Sheath, TTW 0767 K050015 Manufactured by Acumen Medical, Inc. Device Description The Acumen Sheath is a single-use percutaneous catheter indicated f… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062145 | Modified Acumen Lead Delivery Sheath, Models LDS-10-57, LDS-10-57-90, LDS-10-64 and… | 2006 | 2 |
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 4 years and passes through 2 companies; a new generation was cleared every 7 months on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K062145 (Acumen Medical, Inc., 2006) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 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/K051515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051515: Modified Acumen Sheath, Model TTW 10-65.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051515
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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