510(k) Report

FDA applicant

Bigfoot Biomedical, Inc.

Milpitas, CA2 decisions2021–20231 recall

FDA records 2 decisions for Bigfoot Biomedical, Inc. (Milpitas, CA) from 2021 to 2023: 2 510(k) clearances. All are in product code QLG (Integrated Continuous Glucose Monitoring…). Its devices cite 2 predicates, 1 of them its own earlier devices. 1 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 Bigfoot Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

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

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2021high 1 (2025) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — Bigfoot Biomedical, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QLGIntegrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With…2decisions

Whose devices does it build on?

Its devices cite 2 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.

  • K202145Bigfoot Unity Diabetes Management SystemBigfoot Biomedical, Inc. · 20211cites it

What has FDA decided for it lately?

  • K222280Bigfoot Unity® Diabetes Management SystemBigfoot Biomedical, Inc. · 2023
  • K202145Bigfoot Unity Diabetes Management SystemBigfoot Biomedical, Inc. · 20211 recall

All 2 as Bigfoot Biomedical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K202145Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP…May 21, 2025Class II