Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Argon Medical Devices — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
274 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230669 | L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Cat | Argon Medical Devices | 2023-11-30 | 265 | 3 |
| K230631 | Kodiak™ Dual Port Coaxial Introducer Kit | Argon Medical Devices | 2023-05-22 | 76 | 0 |
| K213232 | NovaCore Semi-Automatic Biopsy Instrument | Argon Medical Devices | 2022-07-01 | 274 | 0 |
| K213638 | Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler | Argon Medical Devices | 2021-12-10 | 22 | 0 |
| K213002 | SCORPION Portal Vein Access Set | Argon Medical Devices | 2021-10-14 | 24 | 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