510(k) · Cleared
ClearedExpanding Vascular Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical · DYB Introducer, Catheter
Cleared on Oct 23, 2007 as substantially equivalent to K963886 (Applied Medical Resources, 1997) after a 208-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.
- Decided
- Oct 23, 2007
- Review
- 208 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K890766 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK890766 Catheter Introducer SheathApplied Vascular Devices, Inc. · 1989
- 1 generation backK963886 EVSApplied Medical Resources · 1997
- This deviceK070865 Expanding Vascular SheathApplied Medical · 2007
- Descendant · cites it directly · 0 of its ownK102925 Nexgen Expandable CatheterNexgen Medical Systems, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K102925Nexgen Expandable CatheterNexgen Medical Systems, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K890766 | Catheter Introducer Sheath | Applied Vascular Devices, Inc. | 1989 | — |
| −1 | K963886 | EVS | Applied Medical Resources | 1997 | — |
| 0 (this device) | K070865 | Expanding Vascular Sheath | Applied Medical | 2007 | — |
| +1 | K102925 | Nexgen Expandable Catheter | Nexgen Medical Systems, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K963886 | EVSSummary page 1…legally marketed device: The Applied Medical Expandable Vascular Sheath is substantially equivalent to Applied Medical's Expandable Vascular Sheath approved under 510(k) K963886. Description: The Expandable Vascular Sheath is a sterile single use sheath intended to facilitate the placement and removal of… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102925 | Nexgen Expandable Catheter | 2011 | 0 |
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 18 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K102925 (Nexgen Medical Systems, Inc., 2011) has gone furthest, with 0 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. 2007, 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 Applied Medical Expandable Vascular Sheath is indicated for percutaneous access to the peripheral vascular system and is designed to assist in the placement and removal of catheters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070865 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070865: Expanding Vascular Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070865
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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