Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hyperfine, Inc. — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
46 daysmedian FDA review time
120 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253489 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | 2025-12-12 | 49 | 0 |
| K250236 | Swoop® Portable MR Imaging® System (V2) | Hyperfine, Inc. | 2025-05-30 | 123 | 0 |
| K251276 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | 2025-05-21 | 27 | 0 |
| K240944 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | 2024-07-16 | 102 | 0 |
| K232760 | Swoop® Portable MR Imaging System® | Hyperfine, Inc. | 2023-10-06 | 28 | 0 |
| K230208 | Swoop® Portable MR Imaging System™ | Hyperfine, Inc. | 2023-02-22 | 28 | 0 |
| K223268 | BrainInsight | Hyperfine, Inc. | 2022-12-16 | 53 | 0 |
| K223247 | Swoop Portable MR Imaging System | Hyperfine, Inc. | 2022-12-06 | 46 | 0 |
| K221923 | Swoop Portable MR Imaging System | Hyperfine, Inc. | 2022-07-28 | 27 | 0 |
| K220815 | BrainInsight | Hyperfine, Inc. | 2022-07-19 | 120 | 0 |
| K221393 | Swoop Portable MR Imaging System | Hyperfine, Inc. | 2022-06-10 | 28 | 0 |
| K212456 | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Sca | Hyperfine, Inc. | 2021-11-17 | 104 | 0 |
| K211818 | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Sca | Hyperfine, Inc. | 2021-07-07 | 26 | 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