Hyperfine, Inc.: FDA clearances and approvals
Hyperfine, Inc. has 14 FDA 510(k) clearances (first 2021, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time: 37 days. Since 2017 its median was 37 days, against 123 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov. It files with the SEC as Hyperfine, Inc. (HYPR).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 2 | 65 |
| 2022 | 5 | 46 |
| 2023 | 2 | 28 |
| 2024 | 1 | 102 |
| 2025 | 3 | 49 |
| 2026 | 1 | 22 |
Review time against the same product codes
Since 2017, Hyperfine, Inc.'s cleared 510(k)s took a median 37 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 12 | 12 |
| QIH | Automated Radiological Image Processing Software | 2 | 2 |
Review panels
- Radiology (14)
Most recent Hyperfine, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262622 | Swoop® Portable MR Imaging® System | LNH | 2026-08-19 | 22 |
| K253489 | Swoop® Portable MR Imaging® System | LNH | 2025-12-12 | 49 |
| K250236 | Swoop® Portable MR Imaging® System (V2) | LNH | 2025-05-30 | 123 |
| K251276 | Swoop® Portable MR Imaging® System | LNH | 2025-05-21 | 27 |
| K240944 | Swoop® Portable MR Imaging® System | LNH | 2024-07-16 | 102 |
| K232760 | Swoop® Portable MR Imaging System® | LNH | 2023-10-06 | 28 |
| K230208 | Swoop® Portable MR Imaging System | LNH | 2023-02-22 | 28 |
| K223268 | BrainInsight | QIH | 2022-12-16 | 53 |
| K223247 | Swoop Portable MR Imaging System | LNH | 2022-12-06 | 46 |
| K221923 | Swoop Portable MR Imaging System | LNH | 2022-07-28 | 27 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hyperfine, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Hyperfine, Inc. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07296263: Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems (Enrolling by invitation, started 2025-12-30)
SEC filings
Hyperfine, Inc. (HYPR): EDGAR filings, CIK 1833769. Matched by exact company name.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Hyperfine, Inc.'s product codes (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
Frequently asked questions
How many FDA 510(k) clearances does Hyperfine, Inc. have?
Hyperfine, Inc. has 14 FDA 510(k) clearances (first 2021, latest 2026), across 2 product codes in 1 review panel.
How long does FDA take to clear Hyperfine, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Hyperfine, Inc.'s cleared 510(k)s is 37 days. Since 2017: 37 days, versus 123 days for all cleared 510(k)s in the same product codes.
What devices does Hyperfine, Inc. make?
Its most frequent FDA product codes are LNH (System, Nuclear Magnetic Resonance Imaging, 12); QIH (Automated Radiological Image Processing Software, 2).
Has Hyperfine, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Hyperfine, Inc. Related entities may recall under other names.
Next steps
- See all 14 Hyperfine, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Hyperfine, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.