---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-22-011557"
form_type: "8-K"
ticker: "OM"
cik: "0001484612"
company_name: "Outset Medical, Inc."
filed_at: "2022-06-13T23:59:59+00:00"
generated_at: "2026-06-25T02:19:25.791244+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Outset Medical halts home Tablo shipments pending FDA 510(k) review; guides Q2 rev at least $25M

## Summary
- Shipment hold on new Tablo Hemodialysis Systems for home use pending FDA 510(k) clearance of post-March 2020 changes.
- Q2 2022 revenue expected at least $25M; prior FY2022 guidance suspended until early August update.
- No safety issues identified; Tablo continues to sell for chronic and acute care settings.
- Already-distributed home devices not removed; current users can continue treatment with providers.
- Company expects update on regulatory review process in Q3 2022.

## SEC filing metadata
- accession: 0000950170-22-011557
- form_type: 8-K
- ticker: OM
- cik: 0001484612
- company_name: Outset Medical, Inc.
- filed_at: 2022-06-13T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 2.02, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1484612/000095017022011557/0000950170-22-011557-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1484612/000095017022011557/om-20220613.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-22-011557
- JSON: https://secwatch.observer/filing/0000950170-22-011557.json
- Plain text: https://secwatch.observer/filing/0000950170-22-011557.txt

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