510(k) · Cleared
ClearedInnerdyne Radially Expanding Vascular Access System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innerdyne, Inc. · DYB Introducer, Catheter
Cleared on Oct 10, 1997 as substantially equivalent to K931489 (Innerdyne Medical, Inc., 1993) after an 85-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Oct 10, 1997
- Review
- 85 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931489 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK931489 Intherm Radially Expanding Dilating IntroducerInnerdyne Medical, Inc. · 1993
- This deviceK972684 Innerdyne Radially Expanding Vascular Access SystemInnerdyne, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK980578 Innerdyne Radially Expanding Vascular Access System (Heparin Coated)Innerdyne, Inc. · 1998
Most influential descendants
Showing 1 of 1 · See all- K980578Innerdyne Radially Expanding Vascular Access System (Heparin Coated)Innerdyne, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931489 | Intherm Radially Expanding Dilating Introducer | Innerdyne Medical, Inc. | 1993 | — |
| 0 (this device) | K972684 | Innerdyne Radially Expanding Vascular Access System | Innerdyne, Inc. | 1997 | — |
| +1 | K980578 | Innerdyne Radially Expanding Vascular Access System (Heparin Coated) | Innerdyne, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | K931489 | Intherm Radially Expanding Dilating IntroducerSummary page 1…Dyne, Inc., Radially Expanding Vascular Access System device is substantially equivalent to the predicate InnerDyne, Inc., Radially Expanding Dilating Introducer device (K931489). The subject Radially Expanding Vascular Access System device is similar to the referenced predicate in size, function, product… | 1993 |
| † | K943253 | Innerdyne Step Trocar Expandable Port, S.T.E.P. | 1994 |
| † | K940232 | Innerdyne Step Trocar Expandable Port, S.T.E.P. | 1994 |
| † | K950632 | Innerdyne Step Trocar Expandable Port, Step | 1995 |
| † | K950658 | Innerdyne Step Trocar Expandable Port, Step: | 1995 |
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 |
|---|---|---|---|
| K980578 | Innerdyne Radially Expanding Vascular Access System (Heparin Coated) | 1998 | 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?
- Its one ancestor has no recall.
- Of its descendants, K980578 (Innerdyne, Inc., 1998) 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.
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 InnerDyne, Inc., Radially Expanding Vascular Access System is intended to provide percutaneous access to the vasculature. The Radially Expanding Vascular Access System is indicated for the following usages:
. Percutaneous vascular access.
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/K972684 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972684: Innerdyne Radially Expanding Vascular Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972684
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