Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Argon Medical Devices, Inc. · Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
151 daysmedian FDA review time
266 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252795 | ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore | Argon Medical Devices, Inc. | 2026-02-23 | 174 | 0 |
| K260028 | CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Ca | Argon Medical Devices, Inc. | 2026-02-05 | 31 | 0 |
| K251318 | VariFuse Adjustable Infusion Catheter | Argon Medical Devices, Inc. | 2026-01-20 | 266 | 0 |
| K253741 | V•Stick™ Vascular Access Set | Argon Medical Devices, Inc. | 2025-12-15 | 21 | 0 |
| K242612 | Option ELITE Vena Cava Filter System (352506070E 352506100E) | Argon Medical Devices, Inc. | 2024-09-10 | 7 | 0 |
| K241145 | TLAB® Transvenous Liver Biopsy System (TF-18C) | Argon Medical Devices, Inc. | 2024-08-01 | 98 | 0 |
| K233909 | Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F As | Argon Medical Devices, Inc. | 2024-03-28 | 107 | 0 |
| K232679 | Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Ca | Argon Medical Devices, Inc. | 2024-01-19 | 140 | 0 |
| K233432 | 10F Sheath and Dilator Set | Argon Medical Devices, Inc. | 2023-12-08 | 57 | 0 |
| K232443 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval | Argon Medical Devices, Inc. | 2023-09-07 | 24 | 0 |
| K223176 | Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration | Argon Medical Devices, Inc. | 2023-04-10 | 181 | 0 |
| K211798 | Cleaner Plus Thrombectomy System | Argon Medical Devices, Inc. | 2022-02-24 | 259 | 0 |
| K202141 | Scorpion Stylet Portal Vein Access Set, Scorpion Needle Port | Argon Medical Devices, Inc. | 2021-01-15 | 168 | 0 |
| K200963 | Halo Single-Loop Microsnare Kit | Argon Medical Devices, Inc. | 2021-01-05 | 270 | 0 |
| K201489 | Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 2 | Argon Medical Devices, Inc. | 2020-12-22 | 201 | 0 |
| K200268 | Halo™ Single-Loop Snare Kit | Argon Medical Devices, Inc. | 2020-06-03 | 121 | 0 |
| K191758 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval | Argon Medical Devices, Inc. | 2019-12-17 | 169 | 0 |
| K160785 | Worker Guidewire | Argon Medical Devices, Inc. | 2016-12-08 | 261 | 2 |
| K141969 | FIRSTSTIC N INTRODUCER | Argon Medical Devices, Inc. | 2014-12-19 | 151 | 0 |
| K070384 | ARGON CONTINUOUS FLUSH DEVICE | Argon Medical Devices, Inc. | 2007-03-29 | 48 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda