510(k) · Cleared
ClearedIntroducer Sheath and Dilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · LDF Electrode, Pacemaker, Temporary
Cleared on Jul 23, 1997 after a 114-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Jul 23, 1997
- Review
- 114 days
- Class
- Class II
- Product code
- LDF
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK971165 Introducer Sheath and DilatorBoston Scientific Corp · 1997
- Descendant · cites it directly · 6 of its ownK981611 Snap-N-Peel IntroducersCircon Corp. · 1998
- Descendant · 2 generations on · 5 of its ownK051593 Uropass Ureteral Access Sheath, Model 61224Acmi Corporation · 2005 · Recalled
- Descendant · cites it directly · 3 of its ownK020563 Medamicus Axia RSNMedamicus, Inc. · 2002
- Descendant · 3 generations on · 2 of its ownK120160 Rocamed Rocaus PlatinumPromepla Sam · 2012
- Descendant · 2 generations on · 2 of its ownK022689 Modification to Medamicus Axia RSNMedamicus, Inc. · 2002
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K981611Snap-N-Peel IntroducersCircon Corp. · 1998 · cites it directly6descendants
- K051593Uropass Ureteral Access Sheath, Model 61224Acmi Corporation · 2005 · 2 generations on5descendants
- K020563Medamicus Axia RSNMedamicus, Inc. · 2002 · cites it directly3descendants
- K120160Rocamed Rocaus PlatinumPromepla Sam · 2012 · 3 generations on2descendants
- K022689Modification to Medamicus Axia RSNMedamicus, Inc. · 2002 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971165 | Introducer Sheath and Dilator | Boston Scientific Corp | 1997 | — |
| +1 | K981611 | Snap-N-Peel Introducers | Circon Corp. | 1998 | — |
| +2 | K051593 | Uropass Ureteral Access Sheath, Model 61224 | Acmi Corporation | 2005 | 2 |
| +1 | K020563 | Medamicus Axia RSN | Medamicus, Inc. | 2002 | — |
| +3 | K120160 | Rocamed Rocaus Platinum | Promepla Sam | 2012 | — |
| +2 | K022689 | Modification to Medamicus Axia RSN | Medamicus, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 LDF? 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 LDF device
- #1 K241334 Semi-Floating Temporary Pacing Electrode…score 12.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Cook’s Peel-Away® Introducers Named without a submission number | |
| * | — | B. Braun's Tearaway Introducer Named without a submission number |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K981611 (Circon Corp., 1998) has gone furthest, with 6 descendants of its own.
How does its category compare?
All LDF devicesLDF Electrode, Pacemaker, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDF
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LDF
266in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDF
1in 2018
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LDF
139in 2025
MAUDE reports naming product code LDF, 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 | 0 | — | 0 | 25 |
| 2008 | 1 | — | 2 | 18 |
| 2009 | 0 | — | 2 | 44 |
| 2010 | 0 | — | 0 | 48 |
| 2011 | 0 | — | 1 | 35 |
| 2012 | 0 | — | 1 | 68 |
| 2013 | 0 | — | 0 | 74 |
| 2014 | 1 | — | 0 | 68 |
| 2015 | 2 | — | 0 | 81 |
| 2016 | 3 | 138 | 0 | 90 |
| 2017 | 1 | — | 0 | 79 |
| 2018 | 1 | — | 1 (1) | 91 |
| 2019 | 1 | — | 0 | 130 |
| 2020 | 0 | — | 0 | 83 |
| 2021 | 0 | — | 0 | 125 |
| 2022 | 0 | — | 0 | 117 |
| 2023 | 0 | — | 0 | 212 |
| 2024 | 1 | — | 0 | 190 |
| 2025 | 5 | 266 | 0 | 139 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
The Introducer Sheath and Dilator is used for percutaneous introduction of catheters and guide wires.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971165 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971165: Introducer Sheath and Dilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971165
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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