Argon Medical Devices, Inc.: FDA clearances and approvals
Argon Medical Devices, Inc. has 25 FDA 510(k) clearances (first 2007, latest 2026), across 9 product codes in 3 review panels. Median 510(k) review time: 140 days. Since 2017 its median was 130 days, against 93 days for all cleared 510(k)s in the same product codes. openFDA lists 137 product recalls by a recalling firm named Argon Medical Devices, Inc. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 151 |
| 2015 | 0 | — |
| 2016 | 1 | 261 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 169 |
| 2020 | 2 | 161 |
| 2021 | 4 | 96 |
| 2022 | 2 | 266 |
| 2023 | 5 | 76 |
| 2024 | 4 | 102 |
| 2025 | 1 | 21 |
| 2026 | 3 | 174 |
Review time against the same product codes
Since 2017, Argon Medical Devices, Inc.'s cleared 510(k)s took a median 130 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 93 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYB | Introducer, Catheter | 9 | 9 |
| MMX | Device, Percutaneous Retrieval | 4 | 4 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 4 | 4 |
| KNW | Instrument, Biopsy | 2 | 2 |
| KRA | Catheter, Continuous Flush | 2 | 2 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DTK | Filter, Intravascular, Cardiovascular | 1 | 1 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 1 | 1 |
| QEY | Mechanical Thrombolysis Catheter | 1 | 1 |
Review panels
Most recent Argon Medical Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252795 | ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial | KNW | 2026-02-23 | 174 |
| K260028 | CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister | QEW | 2026-02-05 | 31 |
| K251318 | VariFuse Adjustable Infusion Catheter | QEY | 2026-01-20 | 266 |
| K253741 | VStick Vascular Access Set | DYB | 2025-12-15 | 21 |
| K242612 | Option ELITE Vena Cava Filter System (352506070E 352506100E) | DTK | 2024-09-10 | 7 |
| K241145 | TLAB® Transvenous Liver Biopsy System (TF-18C) | DYB | 2024-08-01 | 98 |
| K233909 | Cleaner Plus 18F Thrombectomy System - Cleaner Plus 18F Aspiration Catheter, Cleaner Plus 18F Handpiece with Maceration Wire, Cleaner Plus 18F Aspiration Canister | QEW | 2024-03-28 | 107 |
| K232679 | Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspiration Canister | QEW | 2024-01-19 | 140 |
| K233432 | 10F Sheath and Dilator Set | DYB | 2023-12-08 | 57 |
| K230669 | L-Cath Single and Dual Lumen Catheters, L-Cath Midline Catheters | LJS | 2023-11-30 | 265 |
15 earlier clearances. See the full list in Caduvo.
Recalls
137 product recalls in 30 recall events; 14 initiated in the last five years. Most recent: 2026-06-15.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Argon Medical Devices, Inc. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07102160: Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking (Recruiting, started 2026-02-04)
- NCT06856655: Achieving Portal Access With Scorpion Post-Approval Study 2 (Completed, started 2022-02-01)
Frequently asked questions
How many FDA 510(k) clearances does Argon Medical Devices, Inc. have?
Argon Medical Devices, Inc. has 25 FDA 510(k) clearances (first 2007, latest 2026), across 9 product codes in 3 review panels.
How long does FDA take to clear Argon Medical Devices, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Argon Medical Devices, Inc.'s cleared 510(k)s is 140 days. Since 2017: 130 days, versus 93 days for all cleared 510(k)s in the same product codes.
What devices does Argon Medical Devices, Inc. make?
Its most frequent FDA product codes are DYB (Introducer, Catheter, 9); MMX (Device, Percutaneous Retrieval, 4); QEW (Peripheral Mechanical Thrombectomy With Aspiration, 4).
Has Argon Medical Devices, Inc. had device recalls?
openFDA lists 137 product recalls in 30 recall events by a recalling firm whose name matches Argon Medical Devices, Inc; the most recent began 2026-06-15. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 25 Argon Medical Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DYB, Argon Medical Devices, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.