Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OAB — Predicate Candidate Screening
14 FDA 510(k) clearances under this product code; the 50 most recent screened below.
179 daysmedian FDA review time
336 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253826 | Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® | Galvanize Therapeutics, Inc. | 2026-05-07 | 157 | 0 |
| K253198 | NanoKnife Generator (H78720300351US0) | Angiodynamics | 2026-03-24 | 179 | 0 |
| K242687 | NanoKnife Generator (H78720300301US0); NanoKnife Single Elec | AngioDynamics, Inc. | 2024-12-06 | 91 | 0 |
| K240376 | Electroporation System (N3000) | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2024-10-04 | 240 | 0 |
| K233884 | INUMI™ Flex Needle | Galvanize Therapeutics, Inc. | 2024-05-22 | 166 | 0 |
| K240297 | Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-10 | Us Medical Innovations, LLC | 2024-05-03 | 92 | 0 |
| K222001 | Irreversible Electroporation Ablation Generator, Irreversibl | Zhejiang Curaway Medical Technology Co., Ltd. | 2023-06-08 | 336 | 0 |
| K212871 | Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Ali | Galvanize Therapeutics, Inc. | 2022-06-17 | 281 | 0 |
| K183385 | NanoKnife System | Angiodynamics | 2019-06-18 | 194 | 1 |
| K150089 | NanoKnife System | AngioDynamics, Inc. | 2015-06-18 | 153 | 0 |
| K102329 | NANOKNIFE SYSTEM | AngioDynamics, Inc. | 2011-10-24 | 433 | 1 |
| K080202 | ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT | Oncobionics, Inc. | 2008-05-08 | 101 | 1 |
| K080376 | ONCOBIONIC SYSTEM | Oncobionic Incorporated | 2008-04-02 | 50 | 1 |
| K060054 | ONCOBIONIC SYSTEM | Oncobionics, Inc. | 2006-11-21 | 319 | 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