---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-183869"
form_type: "8-K"
ticker: "OM"
cik: "0001484612"
company_name: "Outset Medical, Inc."
filed_at: "2023-07-07T23:59:59+00:00"
generated_at: "2026-06-13T11:00:11.245519+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# FDA Warning Letter to Outset Medical over Tablo System promotion and TabloCart clearance

## Summary
- FDA Warning Letter dated July 5, 2023 received July 6, 2023, citing two observations: promotional material for CRRT outside Tablo indications, and TabloCart needing 510(k) clearance.
- Company believes CRRT issue addressed via labeling/promotional changes; TabloCart launched Q3 2022 with immaterial sales to date.
- Warning Letter does not restrict manufacture, shipment, or require withdrawal of Tablo System from U.S. market.
- Company to respond within 15 business days; will cooperate with FDA and may submit 510(k) for TabloCart.

## SEC filing metadata
- accession: 0001193125-23-183869
- form_type: 8-K
- ticker: OM
- cik: 0001484612
- company_name: Outset Medical, Inc.
- filed_at: 2023-07-07T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1484612/000119312523183869/0001193125-23-183869-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1484612/000119312523183869/d511727d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-183869
- JSON: https://secwatch.observer/filing/0001193125-23-183869.json
- Plain text: https://secwatch.observer/filing/0001193125-23-183869.txt

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