# Subtle Medical, Inc.

- Location (FDA's records): Menlo Park, CA
- FDA decisions: 11 (2018–2026): 11 510(k) clearances
- Product codes: LLZ (6), QIH (3), KPS (2)
- 510(k) review time since 2016: median 122 days, against 130 for FDA's reviews in the same codes and years (3 of 11 faster)
- Predicates its devices cite: 12 (6 its own); citations of its devices by later devices: 14 (6 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
- Airs Medical, Inc.: 1 (https://510kreport.com/company/airs-medical)
- Sapheneia Commercial Products AB: 1 (https://510kreport.com/company/sapheneia-commercial-products)
- Zetta Medical Technologies, LLC: 1 (https://510kreport.com/company/zetta-medical-technologies)
- Syntheticmr AB: 1 (https://510kreport.com/company/syntheticmr)
- Claripi, Inc.: 1 (https://510kreport.com/company/claripi)
- Claritas Healthtech Pte, Ltd.: 1 (https://510kreport.com/company/claritas-healthtech)

## Firms that cite its devices most
- Ezra Ai, Inc.: 2 (https://510kreport.com/company/ezra-ai)
- Microstructure Imaging, Inc.: 2 (https://510kreport.com/company/microstructure-imaging)
- Overjet, Inc.: 1 (https://510kreport.com/company/overjet)
- Airs Medical, Inc.: 1 (https://510kreport.com/company/airs-medical)
- Claritas Healthtech Pte, Ltd.: 1 (https://510kreport.com/company/claritas-healthtech)
- Mriguidance B.V.: 1 (https://510kreport.com/company/mriguidance)

## Its most-cited devices
- K191688: SubtleMR (2019), cited by 4
- K203182: SubtleMR (2021), cited by 3
- K223623: SubtleMR (2.3.x) (2023), cited by 3
- K182336: SubtlePET (2018), cited by 2
- K211964: SubtlePET (2021), cited by 2

## Recent decisions
- K254120: SubtleHD-CT (1.x) (May 15, 2026)
- K254013: SubtleHD-PET (1.x) (May 14, 2026)
- K243250: SubtleHD (1.x) (Feb 12, 2025)
- K240290: AiMIFY (1.x) (Aug 21, 2024)
- K241329: SubtleSYNTH (1.x) (Jul 11, 2024)
- K233699: SubtleREFORMAT (1.x) (Apr 29, 2024)
- K223623: SubtleMR (2.3.x) (May 11, 2023)
- K211964: SubtlePET (Sep 28, 2021)

Source page: https://510kreport.com/company/subtle-medical