# Outset Medical, Inc.

- Location (FDA's records): San Jose, CA
- FDA decisions: 10 (2015–2026): 10 510(k) clearances
- Names in FDA's records: Outset Medical, Inc. (9); Outset Medical (1)
- Product codes: KDI (9), FJK (1)
- 510(k) review time since 2016: median 235 days, against 235 for FDA's reviews in the same codes and years (4 of 9 faster)
- Predicates its devices cite: 11 (9 its own); citations of its devices by later devices: 12 (9 its own)
- Recalls linked to its devices: 5 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Home Dialysis Plus: 2 (https://510kreport.com/company/home-dialysis-plus)

## Firms that cite its devices most
- Diality, Inc.: 2 (https://510kreport.com/company/diality)
- Deka Research and Development: 1 (https://510kreport.com/company/deka-research-and-development)

## Its most-cited devices
- K223248: Tablo® Hemodialysis System (2023), cited by 3
- K211370: Tablo Hemodialysis System (2022), cited by 2
- K160881: Tablo Console (2016), cited by 2
- K210782: Tablo Cartridge (2021), cited by 1
- K190793: Tablo Hemodialysis System, Tablo Cartridge (2019), cited by 1
- K233335: Tablo® Hemodialysis System (2023), cited by 1

## Recent decisions
- K253412: Tablo Hemodialysis System (PN-0008000, PN-0006000U) (Jan 26, 2026)
- K232776: Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer (May 3, 2024)
- K233335: Tablo® Hemodialysis System (Dec 5, 2023)
- K223248: Tablo® Hemodialysis System (Jun 21, 2023)
- K211370: Tablo Hemodialysis System (Jul 29, 2022)
- K210782: Tablo Cartridge (Nov 26, 2021)
- K200741: Tablo Hemodialysis System (Mar 31, 2020)
- K190793: Tablo Hemodialysis System, Tablo Cartridge (Dec 12, 2019)

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