510(k) · Cleared
ClearedThe Nanostim Introducer Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St. Jude Medical, Inc. · DYB Introducer, Catheter
Cleared on Apr 14, 2016 as substantially equivalent to K140793 (St. Jude Medical, Inc., 2014) after a 30-day review. Its family tree reaches back 5 generations to 2003. 2 later devices descend from it.
- Decided
- Apr 14, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K032073 (2003). 8 ancestors in all, the oldest K902469 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK032073 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2003
- 4 generations backK082356 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2008
- 3 generations backK093791 Gore Dryseal SheathW. L. Gore & Associates, Inc. · 2010
- 2 generations backK123990 Sentrant Introducer Sheath with Hydrophilic CoatingMedtronic Vascular · 2013
- 1 generation backK140793 Nanostim Introducer KitSt. Jude Medical, Inc. · 2014
- This deviceK160716 The Nanostim Introducer KitSt. Jude Medical, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK161102 Nanostim Introducer KitSt. Jude Medical, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK211989 Aveir IntroducerAbbott Medical · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K032073 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | 2003 | — |
| −4 | K082356 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | 2008 | — |
| −3 | K093791 | Gore Dryseal Sheath | W. L. Gore & Associates, Inc. | 2010 | — |
| −2 | K123990 | Sentrant Introducer Sheath with Hydrophilic Coating | Medtronic Vascular | 2013 | — |
| −1 | K140793 | Nanostim Introducer Kit | St. Jude Medical, Inc. | 2014 | — |
| 0 (this device) | K160716 | The Nanostim Introducer Kit | St. Jude Medical, Inc. | 2016 | — |
| +1 | K161102 | Nanostim Introducer Kit | St. Jude Medical, Inc. | 2016 | — |
| +1 | K211989 | Aveir Introducer | Abbott Medical | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2001 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K140793 | Nanostim Introducer KitSummary page 4…) Predicate Devices: The modified Nanostim Introducer Kit is substantially equivalent in intended use and method of operation to the predicate Nanostim Introducer Kit (K140793). Device Description: The St Jude Medical Nanostim Introducer Kit is designed to perform as a guiding sheath for introduction o… | 2014 |
What descends from it? (2)
2 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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K161102 (St. Jude Medical, Inc., 2016) has gone furthest, with 1 descendant 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. 2016, 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 Nanostim™ Introducer Kit is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160716 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160716: The Nanostim Introducer Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160716
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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