510(k) · Cleared
Recalled · Class I · 2014Alligator Retrieval Device (Ard)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chestnut Medical Technologies, Inc. · DQY Catheter, Percutaneous
Cleared on Mar 24, 2005 after an 86-day review. The FDA summary names its predicate without a number. 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 once, including a Class I recall.
- Decided
- Mar 24, 2005
- Review
- 86 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1 (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 deviceK043580 Alligator Retrieval Device (Ard)Chestnut Medical Technologies, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK093977 Alligator-HD Retrieval Device (Ard-HD), Model FA-88840-XXChestnut Medical Technologies, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K093977Alligator-HD Retrieval Device (Ard-HD), Model FA-88840-XXChestnut Medical Technologies, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043580 | Alligator Retrieval Device (Ard) | Chestnut Medical Technologies, Inc. | 2005 | — |
| +1 | K093977 | Alligator-HD Retrieval Device (Ard-HD), Model FA-88840-XX | Chestnut Medical Technologies, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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.
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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | Boston Scientific "In-Time" retriever Named without a submission number | |
| * | — | Microvena microsnare Named without a submission number |
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 |
|---|---|---|---|
| K093977 | Alligator-HD Retrieval Device (Ard-HD), Model FA-88840-XX | 2010 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 1, 2014 | Class I | Z-1454-2014 | Process change control | Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K093977 (Chestnut Medical Technologies, Inc., 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The Alligator Retrieval Device (ARD) is indicated for the use in retrieval of foreign objects in peripheral and neuro vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043580 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043580: Alligator Retrieval Device (Ard).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043580
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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