510(k) · Cleared
Recalled · Class II · 2020Angiodynamics, Inc., Micro Access Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AngioDynamics, Inc. · DQR Cannula, Catheter
Cleared on Sep 12, 2005 after an 83-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 9 times.
- Decided
- Sep 12, 2005
- Review
- 83 days
- Class
- Class II
- Product code
- DQR
- Recalls
- 9
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 14, 2020 | Class II | Z-0418-2021 | Under Investigation by firm | 5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component |
| Sep 28, 2016 | Class III | Z-0776-2017 | Component design/selection | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub… |
| Sep 28, 2016 | Class III | Z-0773-2017 | Component design/selection | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub… |
| Sep 28, 2016 | Class III | Z-0772-2017 | Component design/selection | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub… |
| Sep 28, 2016 | Class III | Z-0774-2017 | Component design/selection | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub… |
| Sep 28, 2016 | Class III | Z-0775-2017 | Component design/selection | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub… |
| Sep 28, 2016 | Class II | Z-0777-2017 | Component design/selection | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub… |
| Sep 28, 2016 | Class III | Z-0778-2017 | Component design/selection | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub… |
| Apr 30, 2013 | Class II | Z-1405-2013 | Labeling mix-ups | AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the incorrect French size. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All DQR devicesDQR Cannula, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQR
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · DQR
Too few DQR 510(k)s in any year since 2007 to give a median.
Recalls per year · DQR
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQR
6in 2025
MAUDE reports naming product code DQR, 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 | 17 |
| 2008 | 1 | — | 0 | 8 |
| 2009 | 0 | — | 0 | 27 |
| 2010 | 0 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 40 |
| 2016 | 0 | — | 0 | 75 |
| 2017 | 0 | — | 0 | 29 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 0 | 16 |
| 2020 | 0 | — | 1 | 4 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 27 |
| 2023 | 0 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AngioDynamics, Inc. Micro Access Kit is indicated for percutaneous introduction of a
guidewire or catheter into the vascular system following a small 21-gauge needle stick.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K051655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051655: Angiodynamics, Inc., Micro Access Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051655
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026