510(k) Report

FDA applicant

Iterative Scopes, Inc.

Cambridge, MA4 decisions2022–20240 recalls

FDA records 4 decisions for Iterative Scopes, Inc. (Cambridge, MA) from 2022 to 2024: 4 510(k) clearances. All are in product code QNP (Gastrointesinal Lesion Software Detection System). Since 2016 its 510(k)s took a median of 29 days from receipt to decision, against 29 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 3 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 Scopes, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2022: 12023: 12024: 2
2022high 2 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Iterative Scopes, Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Iterative Scopes, Inc.’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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Which product codes does it file in?

  • QNPGastrointesinal Lesion Software Detection System4decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 29 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; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K240781SKOUT® systemIterative Scopes, Inc. · 20242cite it
  • K230658SKOUT® systemIterative Scopes, Inc. · 20231cites it
  • K213686SKOUT SoftwareIterative Scopes, Inc. · 20221cites it
  • K241508SKOUT® systemIterative Scopes, Inc. · 20241cites it

What has FDA decided for it lately?

  • K241508SKOUT® systemIterative Scopes, Inc. · 2024
  • K240781SKOUT® systemIterative Scopes, Inc. · 2024
  • K230658SKOUT® systemIterative Scopes, Inc. · 2023
  • K213686SKOUT SoftwareIterative Scopes, Inc. · 2022

All 4 as Iterative Scopes, Inc. →

Other applicant names beginning “Iterative”

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

Iterative Health 2