510(k) · Cleared
ClearedModified Acumen Lead Delivery Sheath with Stylet, Model: Spirit-10.5-59
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 Feb 17, 2009 as substantially equivalent to K070197 (Acumen Medical, Inc., 2007) after a 55-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Feb 17, 2009
- Review
- 55 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K003731 (2001). No later device cites it as a predicate yet.
- Root · 6 generations backK003731 Safesheath MSP Introducer Sheath Kit with Integral Hemostasis ValveThomas Medical Products, Inc. · 2001 · Recalled
- 5 generations backK042376 Acumen Sheath, Model TTW7807Acumen Medical, Inc. · 2004
- 4 generations backK050015 Modified Acumen Sheath, Model TTWO767Acumen Medical, Inc. · 2005
- 3 generations backK051515 Modified Acumen Sheath, Model TTW 10-65Acumen Medical, Inc. · 2005
- 2 generations backK062145 Modified Acumen Lead Delivery Sheath, Models LDS-10-57…Acumen Medical, Inc. · 2006
- 1 generation backK070197 Acumen Lead Delivery Sheath with Stylet, Models LDS-10-64-Sty and…Acumen Medical, Inc. · 2007
- This deviceK083855 Modified Acumen Lead Delivery Sheath with Stylet, Model…Acumen Medical, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003731 | Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve | Thomas Medical Products, Inc. | 2001 | 6 |
| −5 | K042376 | Acumen Sheath, Model TTW7807 | Acumen Medical, Inc. | 2004 | — |
| −4 | K050015 | Modified Acumen Sheath, Model TTWO767 | Acumen Medical, Inc. | 2005 | — |
| −3 | K051515 | Modified Acumen Sheath, Model TTW 10-65 | Acumen Medical, Inc. | 2005 | — |
| −2 | K062145 | Modified Acumen Lead Delivery Sheath, Models LDS-10-57, LDS-10-57-90… | Acumen Medical, Inc. | 2006 | — |
| −1 | K070197 | Acumen Lead Delivery Sheath with Stylet, Models LDS-10-64-Sty and LDS-10-57-Sty | Acumen Medical, Inc. | 2007 | — |
| 0 (this device) | K083855 | Modified Acumen Lead Delivery Sheath with Stylet, Model: Spirit-10.5-59 | Acumen Medical, Inc. | 2009 | — |
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 |
|---|---|---|---|
| * | K070197 | Acumen Lead Delivery Sheath with Stylet, Models LDS-10-64-Sty and LDS-10-57-StySummary page 1…oduction of various types of pacing or defibrillator leads and catheters. Predicate Devices Acumen Lead Delivery Sheath with Stylet K070197 Manufactured by Acumen Medical, Inc. Device Description The SPIRITTMNavigable Lead Delivery Catheter is a single-use per… | 2007 |
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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 1 of the 6 ancestors has a recall of any class.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 SPIRITTM Navigable Lead Delivery Catheter 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/K083855 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083855: Modified Acumen Lead Delivery Sheath with Stylet, Model: Spirit-10.5-59.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083855
Report an extraction error
Are you the manufacturer?
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