510(k) Report

FDA applicant

Signifier Medical Technologies, Ltd.

London, GB3 decisions2021–20240 recalls

FDA records 3 decisions for Signifier Medical Technologies, Ltd. (London, GB) from 2021 to 2024: 2 510(k) clearances and 1 De Novo grant. All are in product code QNO (Neuromuscular Tongue Muscle Stimulator For The…). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Signifier Medical Technologies”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Signifier Medical Technologies, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2021: 12023: 12024: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Signifier Medical Technologies, Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Signifier Medical Technologies, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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