Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ischemaview, Inc. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
210 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251987 | Rapid Aortic Measurements | Ischemaview, Inc. | 2025-09-23 | 88 | 0 |
| K251533 | Rapid Obstructive Hydrocephalus, Rapid OH | Ischemaview, Inc. | 2025-09-04 | 108 | 0 |
| K252526 | Rapid DeltaFuse | Ischemaview, Inc. | 2025-08-26 | 15 | 0 |
| K243378 | Rapid MLS | Ischemaview, Inc. | 2025-05-28 | 210 | 0 |
| K243350 | Rapid Neuro3D | Ischemaview, Inc. | 2025-01-22 | 86 | 0 |
| K233582 | Rapid | Ischemaview, Inc. | 2024-04-22 | 172 | 0 |
| K232156 | Rapid ASPECTS (v3) | Ischemaview, Inc. | 2024-01-19 | 183 | 0 |
| K233512 | Rapid (6.0) | Ischemaview, Inc. | 2024-01-16 | 76 | 0 |
| K232436 | Rapid SDH | Ischemaview, Inc. | 2023-10-25 | 72 | 0 |
| K230074 | Rapid Aneurysm Triage and Notification | Ischemaview, Inc. | 2023-07-27 | 198 | 0 |
| K222884 | Rapid NCCT Stroke | Ischemaview, Inc. | 2023-03-02 | 161 | 0 |
| K223396 | Rapid RV/LV | Ischemaview, Inc. | 2023-02-01 | 85 | 0 |
| K221456 | Rapid ICH | Ischemaview, Inc. | 2022-09-12 | 116 | 0 |
| K221248 | Rapid LVO | Ischemaview, Inc. | 2022-05-31 | 29 | 0 |
| K220499 | Rapid PE Triage and Notification (PETN) | Ischemaview, Inc. | 2022-05-17 | 84 | 0 |
| K213165 | Rapid | Ischemaview, Inc. | 2022-02-08 | 133 | 0 |
| K200941 | Rapid LVO | Ischemaview, Inc. | 2020-07-09 | 92 | 0 |
| K200760 | Rapid ASPECTS | Ischemaview, Inc. | 2020-06-26 | 94 | 0 |
| K182130 | iSchemaView RAPID | Ischemaview, Inc. | 2018-12-27 | 143 | 0 |
| K172477 | iSchemaView RAPID | Ischemaview, Inc. | 2018-04-19 | 246 | 0 |
| K121447 | ISCHEMA VIEW RAPID | Ischemaview, Inc. | 2013-10-04 | 507 | 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