Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027453514

FEI Number

3027453514

Entity Name

MODULAR MEDICAL

City/State/Country

San Diego, CA, US

Establishment Address

10740 Thornmint Rd, San Diego, CA 92127, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Modular Medical (Owner Number: 10092199)

Owner / Operator Contact Address

10740 Thornmint Rd, San Diego, CA 92127, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K253534

PMA Number

N/A

All Registered Proprietary Names

Pivot Insulin Delivery System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2026-05-07

Official Correspondent

Shahzaib Rai

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Modular Medical

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K082590	Lifescan, Inc.	SYMPHONY METER REMOTE	2008-12-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2013	Animas Corporation	2	IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
Z-0010-05	Medtronic MiniMed	2	Medtronic MiniMed Paradigm Model 712
Z-0011-05	Medtronic MiniMed	2	Medtronic MiniMed Paradigm Model 512

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2029275	Sterigenics U.S., LLC	Corona, CA, US
3012307300	ICU Medical, Inc.	Minneapolis, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027453514. Last updated year: 2026. Please use registration number 3027453514 when referencing this establishment in official correspondence.