FDA-authorised devices built on a large language model

Count of distinct devices the FDA has cleared or authorised whose core function is a large language model, derived metric fda_llm_devices_count over the clearance records. The first is UpDoc (K253281, decision 23 December 2025), per the FDA 510(k) database, STAT News and Innolitics.

Why it matters. The first LLM device through review is the moment the regulated-domain speed limit meets the technology the paper is about; the count after it is the throughput of that limit.

Proxy types

policy

Unit

count

Cadence

quarterly

Valve

adoption to adaptation

• series fda_510k.updoc.first_llm_device_clearance.pt
• series statnews.updoc.first_llm_device_clearance.pt
• series innolitics.updoc.first_llm_device_clearance.pt
• derived metric fda_llm_devices_count (formula in the semantic layer)
• source FDA 510(k) premarket notification database · default tier 4 · Public domain (U.S. government work)
• source Innolitics regulatory articles · default tier 6 · Innolitics; short quotation
• source STAT News · default tier 5 · STAT; short quotation

One device, cleared on a drug-dose-calculator predicate and publicised six months later. The public record does not itself say "LLM"; Innolitics' caveat stands.

3 observations. Hollow points are disputed (see counterevidence). Every point links to its observation.

Evaluator: 1 (FDA 510(k) premarket notification database, 2025-12-23) is inside the consistent band (hi=3). Auto-reason; band rationale: Normal = a handful of LLM-based authorisations by end-2026, given a 510(k) path of roughly six months and a first clearance in December 2025; fast = ten or more, the regulatory throughput a fast scenario needs. Between is `emerging`.

• 2025-12-23 · 1as of 2025-12-23(3 obs)

1. 2026-09-10○unmeasured →to ●consistent with normalconf — → 60 · evaluate

   Evaluator: 1 (FDA 510(k) premarket notification database, 2025-12-23) is inside the consistent band (hi=3). Auto-reason; band rationale: Normal = a handful of LLM-based authorisations by end-2026, given a 510(k) path of roughly six months and a first clearance in December 2025; fast = ten or more, the regulatory throughput a fast scenario needs. Between is `emerging`.

   obs:678d971eobs:8da46094obs:f98335f0

60 / 95 — mixed or hard to operationalise

Confidence is independent of status: 90–95 multiple strong independent sources; 70–89 good evidence, some ambiguity; 50–69 mixed or hard to operationalise; below 50 limited or vague.

• FDA-authorised AI-enabled devices, growth ●consistent with normal
• Waymo paid rides per week ●consistent with normal
• Crosswalk: Adaptation ⇄ Deployment & application (leak from)