# HeartFlow, Inc.

- Location (FDA's records): Redwood City, CA
- FDA decisions: 8 (2014–2025): 7 510(k) clearances and 1 De Novo grant
- Names in FDA's records: HeartFlow, Inc. (7); Heartflow (1)
- Product codes: PJA (8)
- Predicates its devices cite: 9 (7 its own); citations of its devices by later devices: 10 (7 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
- Object Research Systems (Ors), Inc.: 2 (https://510kreport.com/company/object-research-systems-ors)

## Firms that cite its devices most
- Cathworks, Ltd.: 1 (https://510kreport.com/company/cathworks)
- Keyamed Na, Inc.: 1 (https://510kreport.com/company/keyamed-na)
- Elucid Bioimaging, Inc.: 1 (https://510kreport.com/company/elucid-bioimaging)

## Its most-cited devices
- K161772: FFRct (2016), cited by 3
- DEN130045: Heartflow Ffrct (2014), cited by 2
- K213857: HeartFlow Analysis (2022), cited by 1
- K182035: FFRct (2018), cited by 1
- K190925: HeartFlow FFRct Analysis (2019), cited by 1
- K152733: FFRct (2016), cited by 1

## Recent decisions
- K250902: HeartFlow Analysis (Jul 18, 2025)
- K213857: HeartFlow Analysis (Oct 14, 2022)
- K203329: HeartFlow Analysis (Jan 8, 2021)
- K190925: HeartFlow FFRct Analysis (Aug 15, 2019)
- K182035: FFRct (Dec 6, 2018)
- K161772: FFRct (Aug 24, 2016)
- K152733: FFRct (Jan 13, 2016)
- DEN130045: Heartflow Ffrct (Nov 26, 2014)

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