Adaptation · Deployment & application
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.
Reason through thisThe reading
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.
1 reading drawn from the derived metric fda_llm_devices_count; 3 observations in the evidence.
Derived (fda_llm_devices_count) from: FDA 510(k) premarket notification database; STAT News; Innolitics regulatory articles. FDA 510(k) database. STAT News. Innolitics.
The numbers
| as of | reading | value | record |
|---|---|---|---|
| 2025-12-23 | — | 1 | reported |
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.
What cuts against it
The FDA record does not name an LLM; the clearance is narrow (a diabetes dosing app); a count of one is not a rate.
How it is measured
- 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
- proxy policy · cadence quarterly · valve adoption to adaptation
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`.
Applied to metric:fda_llm_devices_count.
Latest readings
- 2025-12-23 · 1as of 2025-12-23(3 obs)
Why this status, and its history
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`.
- 2026-09-10unmeasured to consistent with normalconf — → 60 · the evaluator (automatic)
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`.
Why this confidence
Rests on 3 observations from FDA 510(k) premarket notification database, Innolitics regulatory articles, STAT News; best evidence tier 4, grade A; current.
Confidence is independent of status: 90–95 multiple strong independent sources; 70–89 good evidence, some ambiguity; 50–69 mixed or hard to operationalise; 0–49 limited or vague evidence.