Chrysalis Intelligence · Sponsors · Bigfoot Biomedical, Inc.

Bigfoot Biomedical, Inc.

Milpitas, CA, US · 2 510(k) clearances · 1 recalls

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Total clearances
2
2021-05-07 → 2023-03-01
Last 12 months
0
Product codes
1
Most recent
2023-03-01
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems Class II Clinical Chemistry 2 2023-03-01
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
1
Most recent
2025-05-21
DateSeverityStatusRecall # ProductCodeReason
2025-05-21 Class II Ongoing Z-1997-2025 Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuratio… — Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. …
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2023-03-01 K222280 Bigfoot Unity® Diabetes Management System QLG Class II Clinical Chemistry
2021-05-07 K202145 Bigfoot Unity Diabetes Management System QLG Class II Clinical Chemistry
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence