Cleared Traditional

K240158 - Modular Medical MODD1 Insulin Delivery ...

K240158 is an FDA 510(k) clearance for Modular Medical MODD1 Insulin Delivery ..., 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 229-day FDA review.

K240158 · Modular Medical, Inc. · Chemistry device
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Sep 2024
Decision
229d
Days
Class 2
Risk

K240158 is an FDA 510(k) clearance for the Modular Medical MODD1 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 4, 2024 after a review of 229 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Modular Medical, Inc. devices

FDA 510(k) Submission Details - K240158

510(k) Number K240158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2024
Decision Date September 04, 2024
Days to Decision 229 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
141d slower than avg
Panel avg: 88d · This submission: 229d
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 K240158.
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K192659 · Insulet Corporation · Oct 2019