510(k) · Cleared
Recalled · Class I · 2026Dilator, Vessel & Introducer, Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Argon Medical Corp. · DRE Dilator, Vessel, For Percutaneous Catheterization
Cleared on Mar 2, 1978 after a 37-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 2 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 5 times, including a Class I recall.
- Decided
- Mar 2, 1978
- Review
- 37 days
- Class
- Class II
- Product code
- DRE
- Recalls
- 5 (1 Class I)
- Predicates
- 0
1 later device descends from it, 1 citing it directly. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- This deviceK780126 Dilator, Vessel & Introducer, SheathArgon Medical Corp. · 1978
- Descendant · cites it directly · 0 of its ownK961745 Braun Percutaneous Introducer SetB.Braun Medical, Inc. · 1996 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K961745Braun Percutaneous Introducer SetB.Braun Medical, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K780126 | Dilator, Vessel & Introducer, Sheath | Argon Medical Corp. | 1978 | — |
| +1 | K961745 | Braun Percutaneous Introducer Set | B.Braun Medical, Inc. | 1996 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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 DRE device
- #1 K261310 FlexTract Deflectable-Rotational Dilator…score 12.0 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K961745 | Braun Percutaneous Introducer Set | 1996 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 1, 2026 | Class I | Z-2705-2026 | Material/Component Contamination | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. |
| Jun 19, 2020 | Class II | Z-2806-2020 | Employee error | Sterile introducer sheath set manufactured under one lot with different expiration dates. |
| Apr 8, 2020 | Class II | Z-1938-2020 | Under Investigation by firm | Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the… |
| Feb 17, 2016 | Class II | Z-1029-2016 | Process control | The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheaths and the size 11 product received 7 cm sheaths. |
| Jan 6, 2009 | Not classified | Z-0764-2010 | Other | One lot of Percutaneous Catheter Introducer Set contained incorrect size needle. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K961745 (B.Braun Medical, Inc., 1996) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DRE devicesDRE Dilator, Vessel, For Percutaneous Catheterization: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRE
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRE
1in 2016
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DRE
356in 2025
MAUDE reports naming product code DRE, 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 | 5 | 160 | 0 | 81 |
| 2008 | 2 | — | 0 | 38 |
| 2009 | 2 | — | 2 | 69 |
| 2010 | 1 | — | 2 | 73 |
| 2011 | 1 | — | 1 | 90 |
| 2012 | 1 | — | 0 | 132 |
| 2013 | 4 | 111 | 0 | 120 |
| 2014 | 6 | 72 | 0 | 82 |
| 2015 | 4 | 30 | 1 | 82 |
| 2016 | 3 | 90 | 1 | 84 |
| 2017 | 4 | 108 | 0 | 101 |
| 2018 | 2 | — | 0 | 126 |
| 2019 | 3 | 68 | 0 | 144 |
| 2020 | 3 | 30 | 0 | 120 |
| 2021 | 1 | — | 0 | 115 |
| 2022 | 3 | 261 | 0 | 136 |
| 2023 | 2 | — | 0 | 386 |
| 2024 | 1 | — | 0 | 325 |
| 2025 | 3 | 31 | 0 | 356 |
| 2026 | 1 | — | 1 (1) | — |
https://510kreport.com/device/K780126 · printed Nov 5, 2026
Cite this page
510(k) Report. “K780126: Dilator, Vessel & Introducer, Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K780126
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026