Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
POK — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
138 daysmedian FDA review time
216 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253884 | Koios DS (3.8) | Koios Medical, Inc. | 2026-07-02 | 210 | 0 |
| K261519 | Sonio Suspect | Sonio | 2026-06-04 | 28 | 0 |
| K254161 | Automated Aortic Stenosis Software (AutoAS) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026-03-27 | 95 | 0 |
| K251769 | RevealAI-Lung | Precision Medical Ventures, Inc. Dba Revealdx | 2026-01-30 | 234 | 0 |
| K252294 | Fetal EchoScan (v1.2) | Brightheart | 2025-12-08 | 138 | 0 |
| K250221 | StrokeSENS ASPECTS Software Application | Circle Cardiovascular Imaging, Inc. | 2025-07-01 | 158 | 0 |
| K251071 | Fetal EchoScan (v1.1) | Brightheart | 2025-05-02 | 25 | 0 |
| K243614 | Sonio Suspect | Sonio | 2025-02-21 | 91 | 0 |
| K243294 | Brainomix 360 e-ASPECTS | Brainomix Limited | 2025-02-14 | 119 | 0 |
| K242130 | Koios DS | Koios Medical, Inc. | 2024-11-15 | 116 | 0 |
| K242342 | Fetal EchoScan | Brightheart | 2024-11-14 | 99 | 0 |
| K241245 | EchoSolv AS | Echo IQ, Ltd. | 2024-10-04 | 154 | 0 |
| K234141 | AISAP Cardio V1.0 | Aisap | 2024-08-01 | 216 | 0 |
| K233342 | CINA-ASPECTS | Avicenna.Ai | 2024-03-15 | 168 | 0 |
| K232156 | Rapid ASPECTS (v3) | Ischemaview, Inc. | 2024-01-19 | 183 | 0 |
| K221564 | Brainomix 360 e-ASPECTS | Brainomix Limited | 2023-02-23 | 268 | 0 |
| K221624 | Avenda Health AI Prostate Cancer Planning Software | Avenda Health, Inc. | 2022-11-22 | 169 | 0 |
| K212616 | Koios DS | Koios Medical, Inc. | 2021-12-16 | 120 | 0 |
| K202300 | Optellum Virtual Nodule Clinic, Optellum software, Optellum | Optellum, Ltd. | 2021-03-05 | 204 | 0 |
| K201555 | EchoGo Pro | Ultromics, Ltd. | 2020-12-18 | 191 | 0 |
| K200760 | Rapid ASPECTS | Ischemaview, Inc. | 2020-06-26 | 94 | 0 |
| K190442 | Koios DS for Breast | Koios Medical, Inc. | 2019-07-03 | 128 | 0 |
| DEN170022 | QuantX | Quantitative Insights, Inc. | 2017-07-19 | 103 | 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