Cleared Traditional

K262153 - Pivot Insulin Delivery System

K262153 is an FDA 510(k) clearance for Pivot Insulin Delivery System, manufactured by Modular Medical, Inc.. The device is a Class 2 Chemistry device with product code LZG cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K262153 · Modular Medical, Inc. · Chemistry device
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Sep 2026
Decision
68d
Days
Class 2
Risk

K262153 is an FDA 510(k) clearance for the Pivot Insulin Delivery System. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Modular Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on September 2, 2026 after a review of 68 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Modular Medical, Inc. devices

FDA 510(k) Submission Details - K262153

510(k) Number K262153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2026
Decision Date September 02, 2026
Days to Decision 68 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
20d faster than avg
Panel avg: 88d · This submission: 68d
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 78
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K262153.
Pivot Insulin Delivery System
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Extended Reservoir
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Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
K211575 · Insulet Corporation · Aug 2021