---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-053215"
form_type: "8-K"
ticker: "OM"
cik: "0001484612"
company_name: "Outset Medical, Inc."
filed_at: "2024-05-06T23:59:59+00:00"
generated_at: "2026-06-02T21:56:23.565340+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Outset Medical receives FDA 510(k) clearance for TabloCart with Prefiltration; resumes distribution

## Summary
- FDA granted 510(k) clearance for TabloCart with Prefiltration, an accessory for the Tablo Hemodialysis System.
- Outset has resumed distribution and has product available to ship to U.S. customers.
- TabloCart features three customizable prefiltration options and a booster pump for variable water conditions.
- CEO Leslie Trigg states clearance enhances flexibility for nurses and health systems from ICU to bedside.

## SEC filing metadata
- accession: 0000950170-24-053215
- form_type: 8-K
- ticker: OM
- cik: 0001484612
- company_name: Outset Medical, Inc.
- filed_at: 2024-05-06T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1484612/000095017024053215/0000950170-24-053215-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1484612/000095017024053215/om-20240506.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-053215
- JSON: https://secwatch.observer/filing/0000950170-24-053215.json
- Plain text: https://secwatch.observer/filing/0000950170-24-053215.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.