# Bay Labs, Inc.

- Location (FDA's records): San Francisco, CA
- FDA decisions: 2 (2018–2020): 1 510(k) clearance and 1 De Novo grant
- Product codes: QJU (1), LLZ (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 7 (0 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
- Diacardio, Ltd.: 1 (https://510kreport.com/company/diacardio)

## Firms that cite its devices most
- Caption Health: 2 (https://510kreport.com/company/caption-health)
- Ultrasight, Ltd.: 1 (https://510kreport.com/company/ultrasight)
- Dyad Medical, Inc.: 1 (https://510kreport.com/company/dyad-medical)
- Eko.Ai Pte Ltd. D/B/A Us2.Ai: 1 (https://510kreport.com/company/eko-ai-d-b-a-us2-ai)
- Deski: 1 (https://510kreport.com/company/deski)
- ThinkSono GmbH: 1 (https://510kreport.com/company/thinksono)

## Its most-cited devices
- DEN190040: Caption Guidance (2020), cited by 4
- K173780: EchoMD Automated Ejection Fraction Software (2018), cited by 3

## Recent decisions
- DEN190040: Caption Guidance (Feb 7, 2020)
- K173780: EchoMD Automated Ejection Fraction Software (Jun 14, 2018)

Source page: https://510kreport.com/company/bay-labs