---
schema_version: "secwatch.filing_event.v1"
accession: "0000898432-22-000616"
form_type: "8-K"
ticker: "IRMD"
cik: "0001325618"
company_name: "IRADIMED CORP"
filed_at: "2022-10-11T23:59:59+00:00"
generated_at: "2026-06-23T04:17:51.823936+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Iradimed withdraws 510(k) for MRidium 3870 pump; Q3 revenue $13.4M beats guidance

## Summary
- Voluntarily withdrew 510(k) for MRidium 3870 Infusion Pump on Oct 5; plans to resubmit after FDA talks.
- Preliminary Q3 revenue ~$13.4M, up 23% YoY, above guidance of $13.1–$13.3M.
- Record quarterly revenue; fourth consecutive record quarter; orders exceeded shipments.
- Domestic orders for current MRidium 3860 system were highest in three years.
- CEO states withdrawal does not affect current revenue-generating product portfolio.

## SEC filing metadata
- accession: 0000898432-22-000616
- form_type: 8-K
- ticker: IRMD
- cik: 0001325618
- company_name: IRADIMED CORP
- filed_at: 2022-10-11T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 2.02, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1325618/000089843222000616/0000898432-22-000616-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1325618/000089843222000616/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000898432-22-000616
- JSON: https://secwatch.observer/filing/0000898432-22-000616.json
- Plain text: https://secwatch.observer/filing/0000898432-22-000616.txt

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