AngioDynamics, Inc.: FDA filings under this applicant name
FDA lists 90 510(k) clearances under the applicant name “AngioDynamics, Inc.” (first 1995, latest 2026), across 20 product codes in 4 review panels. Median 510(k) review time under this name: 82 days. Since 2017 the median was 108 days, against 107 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 182 |
| 2013 | 2 | 22 |
| 2014 | 3 | 58 |
| 2015 | 3 | 116 |
| 2016 | 1 | 30 |
| 2017 | 9 | 84 |
| 2018 | 2 | 148 |
| 2019 | 3 | 192 |
| 2020 | 3 | 238 |
| 2021 | 3 | 59 |
| 2022 | 1 | 172 |
| 2023 | 3 | 116 |
| 2024 | 2 | 72 |
| 2025 | 2 | 69 |
| 2026 | 1 | 179 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name AngioDynamics, Inc. took a median 108 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 16 | 16 |
| DQO | Catheter, Intravascular, Diagnostic | 11 | 11 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 10 | 10 |
| QEY | Mechanical Thrombolysis Catheter | 6 | 6 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 5 | 5 |
| NEY | System, Ablation, Microwave And Accessories | 5 | 5 |
| OAB | Low Energy Direct Current Thermal Ablation System | 5 | 5 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 4 | 4 |
| DYB | Introducer, Catheter | 4 | 4 |
| MSD | Catheter, Hemodialysis, Implanted | 4 | 4 |
Plus 10 more product codes.
Review panels
- Cardiovascular (36)
- General and Plastic Surgery (28)
- General Hospital (17)
- Gastroenterology and Urology (9)
Most recent AngioDynamics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253198 | NanoKnife Generator (H78720300351US0) | OAB | 2026-03-24 | 179 |
| K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885 | QEZ | 2025-11-24 | 108 |
| K253106 | AngioVac Cannula | DWF | 2025-10-24 | 30 |
| K242687 | NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010) | OAB | 2024-12-06 | 91 |
| K240397 | AlphaVac MMA F1885 System (H787253020) | QEZ | 2024-04-01 | 52 |
| K231945 | VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits | GEX | 2023-07-20 | 20 |
| K223581 | Solero Microwave Tissue Ablation (MTA) System and Accessories | NEY | 2023-03-27 | 116 |
| K221883 | Solero Microwave Tissue Ablation (MTA) System and Accessories | NEY | 2023-03-07 | 251 |
| K213388 | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | QEZ | 2022-04-04 | 172 |
| K213067 | Solero Microwave Tissue Ablation (MTA) System and Accessories | NEY | 2021-12-03 | 71 |
80 earlier clearances. See the full list in Caduvo.
Recalls
135 product recalls in 35 recall events; 59 initiated in the last five years. Most recent: 2026-03-03.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named AngioDynamics, Inc. is the lead sponsor of 13 device studies on ClinicalTrials.gov (5 active or recruiting). Most recent:
- NCT07280247: Acute Pulmonary Embolism Treatment With the AlphaVac Multipurpose Mechanical Aspiration System and the AlphaReturn Blood Management System: Evaluation of Safety and Effectiveness (Recruiting, started 2026-03-30)
- NCT06697314: Evaluating the Efficacy, Safety and Long Term Functional Outcomes of Percutaneous Mechanical Aspiration Thrombectomy for Treatment of Acute Pulmonary Embolism Using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System (Recruiting, started 2025-06-15)
- NCT06777901: Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone (Recruiting, started 2025-04-21)
- NCT05318092: Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism (Completed, started 2022-10-19)
- NCT04972097: Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue (Completed, started 2022-03-29)
SEC filings
ANGIODYNAMICS INC (ANGO): EDGAR filings, CIK 1275187. An SEC registrant with the same name, matched by name only.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under AngioDynamics, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Angiodynamics, Div. E-Z-Em, Inc. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under AngioDynamics, Inc.?
FDA lists 90 510(k) clearances under the applicant name “AngioDynamics, Inc.” (first 1995, latest 2026), across 20 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by AngioDynamics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name AngioDynamics, Inc. is 82 days. Since 2017: 108 days, versus 107 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under AngioDynamics, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 16); DQO (Catheter, Intravascular, Diagnostic, 11); LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 10).
Next steps
- See all 90 AngioDynamics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, AngioDynamics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.