510(k) Report

FDA applicant

Odin Medical Limited

London, GB3 decisions2024–20260 recalls

FDA records 3 decisions for Odin Medical Limited (London, GB) from 2024 to 2026: 3 510(k) clearances. All are in product code QNP (Gastrointesinal Lesion Software Detection System). Since 2016 its 510(k)s took a median of 201 days from receipt to decision, against 29 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Odin Medical Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2024: 12025: 12026 (partial year): 1
2024high 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Odin Medical Limited by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QNPGastrointesinal Lesion Software Detection System3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 201 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 29 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K252586CaddieOdin Medical Limited · 20251cites it
  • K240044CaddieOdin Medical Limited · 20241cites it

What has FDA decided for it lately?

  • K260133CaddieOdin Medical Limited · 2026
  • K252586CaddieOdin Medical Limited · 2025
  • K240044CaddieOdin Medical Limited · 2024

All 3 as Odin Medical Limited →

Other applicant names beginning “Odin”

FDA records each applicant name separately; these may or may not be the same firm.

Odin Medical Technologies, Ltd. 5Odin Technologies, Ltd. 2