510(k) Report

FDA applicant

Intuity Medical, Inc.

Sunnyvale, CA3 decisions2016–20180 recalls

FDA records 3 decisions for Intuity Medical, Inc. (Sunnyvale, CA) from 2016 to 2018: 3 510(k) clearances. All are in product code NBW (System, Test, Blood Glucose, Over The Counter). Since 2016 its 510(k)s took a median of 237 days from receipt to decision, against 233 for FDA’s reviews in the same codes and years. Its devices cite 4 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, clinical chemistry panel, where it files most

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

FDA decisions per year

1in 2018

2016: 12017: 12018: 1
2016high 1 (2016) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Intuity Medical, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NBWSystem, Test, Blood Glucose, Over The Counter3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 237 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 233 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 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.

  • K162203POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. · 20171cites it

What has FDA decided for it lately?

  • K181316POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. · 2018
  • K162203POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. · 2017
  • K152493POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. · 2016

All 3 as Intuity Medical, Inc. →