Cleared Traditional

K210714 - Extended Reservoir

K210714 is an FDA 510(k) clearance for Extended Reservoir, manufactured by Medtronic Minimed, Inc.. The device is a Class 2 Chemistry device with product code LZG cleared through the Traditional 510(k) pathway after a 392-day FDA review.

K210714 · Medtronic Minimed, Inc. · Chemistry device
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Apr 2022
Decision
392d
Days
Class 2
Risk

K210714 is an FDA 510(k) clearance for the Extended Reservoir. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Medtronic Minimed, Inc. (Northridge, US). The FDA issued a Cleared decision on April 6, 2022 after a review of 392 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 880.5725 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Minimed, Inc. devices

FDA 510(k) Submission Details - K210714

510(k) Number K210714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2021
Decision Date April 06, 2022
Days to Decision 392 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
304d slower than avg
Panel avg: 88d · This submission: 392d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZG Device Classification - Class 2, Special Controls

Product Code LZG Pump, Infusion, Insulin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - LZG Pump, Infusion, Insulin

All 43
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K210714.
Modular Medical MODD1 Insulin Delivery System
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K211575 · Insulet Corporation · Aug 2021
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
K192659 · Insulet Corporation · Oct 2019
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
K182630 · Insulet Corporation · Jan 2019