FDA Class II

Veridian Insulin Delivery System (VID-100)

510(k) Number: K220893

Automated insulin infusion pump with integrated continuous glucose monitoring connectivity for Type 1 diabetes management.

Canonical URL: /regulatory/devices/veridian-insulin-pump-k220893.html

510(k) Number: K220893

Product Code: FRN

Regulation: 21 CFR 880.5730

UDI-DI: 00842684703456

Decision Date: 2022-06-08

Manufacturing Site: MFG-AUS-002

510(k) Clearance Summary

Field	Value
Device Name	Veridian Insulin Delivery System, Model VID-100
510(k) Number	K220893
Decision Date	June 8, 2022
Product Code	FRN — Pump, infusion, insulin
Regulation Number	21 CFR 880.5730
Predicate Device	InsulinFlow 3000 (510(k) K180456)
Manufacturing Site	8400 Tech Ridge Blvd, Austin, TX 78753 (FEI 3012345679)

The VID-100 is indicated for subcutaneous delivery of insulin at programmed rates for patients with diabetes mellitus requiring insulin.

Automated insulin dosing features require pairing with an FDA-cleared continuous glucose monitor; only Veridian Glucose Patch VGP-200 and approved third-party CGMs listed in IFU Section 6 are authorized.

Maximum single bolus dose is limited to 25 units by software lock; override requires physician authorization code entered in clinician portal.

All insulin pump occlusions, over-delivery events, and under-delivery events must be logged and evaluated for MDR reportability within 5 business days.

Safety & Alarm Specifications

Alarm Condition	Alarm Type	Response Time	User Action Required
Occlusion detected	Critical (audible + vibrate)	< 30 seconds	Check infusion set, replace if needed
Low reservoir (<20 units)	Warning	Immediate	Refill or replace cartridge
Low battery (<15%)	Warning	Immediate	Charge or replace battery
CGM signal lost >20 min	Warning	Continuous until resolved	Check CGM sensor and connectivity
Maximum daily dose exceeded	Critical	Immediate	Contact healthcare provider

Recall & Field Action History

Date	Action Type	Reason	Units Affected	FDA Recall #	Status
Aug 2023	Field Correction	Software bug causing incorrect bolus calculator display	2,847	Z-1847-2023	Closed
Mar 2024	Software Update	CGM integration stability improvement (non-recall)	8,120	—	Complete

All field corrections and recalls must follow 21 CFR Part 806 reporting requirements with FDA notification within required timeframes.