510(k) Report

FDA applicant

Iterative Health

Cambridge, MA2 decisions2025–20250 recalls

FDA records 2 decisions for Iterative Health (Cambridge, MA) in 2025: 2 510(k) clearances. All are in product code QNP (Gastrointesinal Lesion Software Detection System). Its devices cite 3 predicates, 1 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 Iterative Health’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2025: 2
2025high 2 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Iterative Health by year, 2025–2026Sources: 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 System2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 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.

  • K251126SKOUT systemIterative Health · 20251cites it

What has FDA decided for it lately?

  • K253664SKOUT systemIterative Health · 2025
  • K251126SKOUT systemIterative Health · 2025

All 2 as Iterative Health →

Other applicant names beginning “Iterative”

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

Iterative Scopes, Inc. 4