f**k EHR

Signals · FDA in the wild

Cleared, approved, or neither.

Healthcare AI marketing implies regulatory legitimacy that often doesn't exist. This page shows what the FDA has actually cleared — and what's notably missing from the database. Pulled at build time from openFDA.

Recent 510(k) clearances

FDA clearances under product codes the agency groups under AI/ML-enabled medical devices: QIH, QFM, QAS, POK, QPF, QQA, MYN, LLZ.

Notably absent

Ambient AI scribes are mostly outside FDA jurisdiction.

Not because they're safer. Because the FDA's medical-device pathway doesn't cleanly cover transcription-and-summarization tools that produce text for a clinician to review. Vendors generally market under "Clinical Decision Support" and "documentation efficiency" framings that fall outside the 510(k) regime. None of the following appear in the openFDA 510(k) database for AI-enabled devices at build time:

  • Abridge — Ambient documentation. Not 510(k) cleared.
  • Microsoft DAX Copilot (Nuance) — Ambient documentation. Not 510(k) cleared.
  • Suki — Ambient documentation. Not 510(k) cleared.
  • Nabla — Ambient documentation. Not 510(k) cleared.
  • DeepScribe — Ambient documentation. Not 510(k) cleared.
  • Augmedix — Ambient documentation. Not 510(k) cleared.
  • Ambience Healthcare — Ambient documentation. Not 510(k) cleared.

Absence from the 510(k) database is not an accusation; it's a statement of regulatory scope. The point is that FDA clearance cannot be assumed, and "AI in healthcare" should not be read as "AI cleared by the FDA."

openFDA disclaimer applies: data is unvalidated, do not rely on it for medical decisions. Updated at build · 2026-05-15.