# Hyperfine, Inc.

- Location (FDA's records): Guilforf, CT
- FDA decisions: 14 (2021–2026): 14 510(k) clearances
- Product codes: LNH (12), QIH (2)
- 510(k) review time since 2016: median 37 days, against 122 for FDA's reviews in the same codes and years (12 of 14 faster)
- Predicates its devices cite: 15 (12 its own); citations of its devices by later devices: 12 (12 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hyperfine Research, Inc.: 3 (https://510kreport.com/company/hyperfine-research)

## Its most-cited devices
- K240944: Swoop® Portable MR Imaging® System (2024), cited by 2
- K250236: Swoop® Portable MR Imaging® System (V2) (2025), cited by 1
- K220815: BrainInsight (2022), cited by 1
- K230208: Swoop® Portable MR Imaging System™ (2023), cited by 1
- K223247: Swoop Portable MR Imaging System (2022), cited by 1
- K221923: Swoop Portable MR Imaging System (2022), cited by 1

## Recent decisions
- K262622: Swoop® Portable MR Imaging® System (Aug 19, 2026)
- K253489: Swoop® Portable MR Imaging® System (Dec 12, 2025)
- K250236: Swoop® Portable MR Imaging® System (V2) (May 30, 2025)
- K251276: Swoop® Portable MR Imaging® System (May 21, 2025)
- K240944: Swoop® Portable MR Imaging® System (Jul 16, 2024)
- K232760: Swoop® Portable MR Imaging System® (Oct 6, 2023)
- K230208: Swoop® Portable MR Imaging System™ (Feb 22, 2023)
- K223268: BrainInsight (Dec 16, 2022)

Source page: https://510kreport.com/company/hyperfine