Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014585508

FEI Number

3014585508

Entity Name

Insulet Corporation

City/State/Country

Acton, MA, US

Establishment Address

100 Nagog Park, Acton, MA 01720, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

INSULET CORPORATION (Owner Number: 9056196)

Owner / Operator Contact Address

100 Nagog Park, --, Acton, MA 01720, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211575

PMA Number

N/A

All Registered Proprietary Names

PodPals Adhesive Overlay Amgen Adhesive Overlay Omnipod Discover Omnipod 5 Pod On-body Injector for Neulasta Omnipod 5 SmartAdjust Omnipod 5 Pod Omnipod GO Insulin Delivery Device, 5-Pack 10U Omnipod GO Insulin Delivery Device, 5-Pack 35U Omnipod GO Insulin Delivery Device, 5-Pack 30U Omnipod GO Insulin Delivery Device, 5-Pack 15U Omnipod GO Insulin Delivery Device, 5-Pack 40U Omnipod GO Insulin Delivery Device, 5-Pack 25U Omnipod GO Insulin Delivery Device, 5-Pack 20U Omnipod Dash Omnipod

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2019-05-21
PHV	Continuous Glucose Monitor Retrospective Data Analysis Software	Clinical Chemistry	Class 1	862.2120	2023-11-30
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2024-07-09
KZH	Introducer, Syringe Needle	General Hospital	Class 2	880.6920	2015-02-20
QJI	Interoperable Automated Glycemic Controller	Clinical Chemistry	Class 2	862.1356	2024-09-09
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2019-12-05
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2023-11-27
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2023-05-16
NDC	Calculator, Drug Dose	Anesthesiology	Class 2	868.1890	2021-11-04
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2021-11-04
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2021-11-04

Official Correspondent

Chuck Medovich

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INSULET CORPORATION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3030970576	Insulet Malaysia Sdn. Bhd.	Iskandar Puteri Johor, MY

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
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
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014585508. Last updated year: 2026. Please use registration number 3014585508 when referencing this establishment in official correspondence.