Biovalve Insulin Delivery Systems (Bids)

FDA 510(k) K050971 · Biovalve Technologies, Inc.

Substantially Equivalent

510(k) numberK050971

Submission

Device name
Biovalve Insulin Delivery Systems (Bids)
Applicant
Biovalve Technologies, Inc.
Westborough, MA, US
Received
April 18, 2005
Decision date
August 16, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LZG – Pump, Infusion, Insulin
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Specialty
General Hospital

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K262153Pivot Insulin Delivery SystemLZG · Traditional Modular Medical, Inc.09/02/2026SE
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K240158Modular Medical MODD1 Insulin Delivery SystemLZG · Traditional Modular Medical, Inc.09/04/2024SE
K241622Extended Reservoir; MiniMed ReservoirLZG · Special Medtronic Minimed07/02/2024SE
K223372Omnipod GO Insulin Delivery DeviceLZG · Traditional Insulet Corporation04/24/2023SE
K210714Extended ReservoirLZG · Traditional Medtronic Minimed, Inc.04/06/2022SE
K211575Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemLZG · Traditional Insulet Corporation08/13/2021SE
K192659Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG · Traditional Insulet Corporation10/21/2019SE
K182630Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG · Traditional Insulet Corporation01/08/2019SE
K180045Omnipod DASH Insulin Management SystemLZG · Traditional Insulet Corporation06/01/2018SE

More from Insulet Corporation

510(k)DeviceDecision
K051985Biovalve Mini-Ject Needlefree InjectorKZE · Special 08/17/2005SE
K032976Biovalve Miniject Needle-Free Injection System, Model FG-01-001KZE · Traditional 04/16/2004SE

Questions and answers

When was Biovalve Insulin Delivery Systems (Bids) cleared by the FDA?

Biovalve Insulin Delivery Systems (Bids) (K050971) received a 510(k) decision of Substantially Equivalent on August 16, 2005, 120 days after the submission was received.

What is the product code of K050971?

The FDA product code is LZG – Pump, Infusion, Insulin, a Class II (moderate risk) device regulated under 21 CFR 880.5725.