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Insulet Corporation

United States·US-MF-000007948

Last updated September 17, 2026

About

Simplify life with our tubeless, waterproof insulin pod. Omnipod® delivers continuous insulin with no injections. Discover if Omnipod® is right for you.

From the manufacturer's own website. Source

Information

Country: United States
Address: 100, Nagog Park, Acton - Massachusetts, United States
Website: www.omnipod.com
LinkedIn: —
Facebook: facebook.com/myomnipod
Email: [email protected]
Phone: +19786007000
PRRC Contact: Thom McNamara
EUDAMED SRN: US-MF-000007948
FDA FEI Number: 3014585508
DUNS Number: —

Catalogue (59)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Omnipod Discover	PT-001083	EUDAMED	Class IIa	Active
Omnipod Insulin Management System	NLT450	EUDAMED	Class IIb	Active
Omnipod Go Insulin Delivery Device 20U/day	POD-INS-I1-2025	FDA UDI	Class II	Active
Omnipod 5 Controller	PDM-H001-G-XX	FDA UDI	Class II	Active
Omnipod	UST400	FDA UDI	Class II	Active
Omnipod 5 Pod	POD-BLE-H1-520	FDA UDI	Class II	Active
Omnipod (Dash) View APP	1.3.1	FDA UDI	Class II	Active
Omnipod	ZXP420	FDA UDI	Class II	Active
Omnipod 5 Controller APP	M009-S-AP	FDA UDI	Class II	Active
Omnipod 5 Controller APP	M009-3P-AP	FDA UDI	Class II	Active
Omnipod 5 Pod	POD-OMNI-I1-6720	FDA UDI	Class II	Active
Omnipod Go Insulin Delivery Device 30U/day	POD-INS-I1-3025	FDA UDI	Class II	Active
Omnipod DASH Pod	POD-BLE-11-520	FDA UDI	Class II	Active
Omnipod Go Insulin Delivery Device 40U/day	POD-INS-I1-4025	FDA UDI	Class II	Active
Omnipod 5 Controller APP	1.0	FDA UDI	Class II	Active
Omnipod Go Insulin Delivery Device 15U/day	POD-INS-I1-1525	FDA UDI	Class II	Active
Omnipod (Dash) Display App.	1.3.1	FDA UDI	Class II	Active
Omnipod DASH PDM	PDM-USA1-D001-MG-USA1	FDA UDI	Class II	Active
Omnipod Go Insulin Delivery Device 35U/day	POD-INS-I1-3525	FDA UDI	Class II	Active
Omnipod	UST400	FDA UDI	Class II	Active
Omnipod Go Insulin Delivery Device 10U/day POD	POD-INS-I1-1025	FDA UDI	Class II	Active
Omnipod Go Insulin Delivery Device 25U/day	POD-INS-I1-2525	FDA UDI	Class II	Active
Omnipod 5 Starter Kit	SKT-M001-G-X9	FDA UDI	Class II	Active
SmartBolus Calculator	K222239	FDA 510(k)	Class II	Active
Omnipod 5 ACE Pump (Pod)	K203768	FDA 510(k)	Class II	Active
Omnipod 5 SmartBolus Calculator	K203772	FDA 510(k)	Class II	Active
Ixl-Ii Diabetes Management System	K042792	FDA 510(k)	Class II	Active
SmartAdjust(TM) technology	K220394	FDA 510(k)	Class II	Active
Ixl Diabetes Management System	K031373	FDA 510(k)	Class II	Active
SmartBolus Calculator	K231824	FDA 510(k)	Class II	Active
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System	K211575	FDA 510(k)	Class II	Active
SmartAdjust(TM) technology	K232741	FDA 510(k)	Class II	Active
Freestyle Glucose Meter Incorporated Into The Omnipod Insulin Management Systems	K111669	FDA 510(k)	Class II	Active
Omnipod DASH Insulin Management System	K180045	FDA 510(k)	Class II	Active
Omnipod 5 algorithm	K251779	FDA 510(k)	Class II	Active
Omnipod GO Insulin Delivery Device	K223372	FDA 510(k)	Class II	Active
SmartAdjust technology	K203774	FDA 510(k)	Class II	Active
SmartAdjust™ Technology	K241777	FDA 510(k)	Class II	Active
Omnipod DASH Insulin Management System with interoperable technology	K191679	FDA 510(k)	Class II	Active
Omnipod 5 ACE Pump	K231826	FDA 510(k)	Class II	Active
Omnipod Insulin Management System, Omnipod DASH Insulin Management System	K182630	FDA 510(k)	Class II	Active
PodPals Adhesive Overlay	POD-X9-990NS	EUDAMEDFDA UDI	Class I	Active
Omnipod Insulin Management System	18900-5E	EUDAMED	Class IIb	Active
Omnipod Insulin Management System	ZXP420	EUDAMEDFDA UDI	Class IIb	Active
Omnipod Insulin Management System	18916-5N	EUDAMED	Class IIb	Active
Omnipod Insulin Management System	18900-5F	EUDAMED	Class IIb	Active
Omnipod Insulin Management System	18916-6G	EUDAMED	Class IIb	Active
Omnipod Insulin Management System	ZXP425	EUDAMED	Class IIb	Active
PodPals Adhesive Overlay	POD-X9-990	EUDAMEDFDA UDI	Class I	Active
Ferring Drug Delivery System	ZXG630	EUDAMED	Class IIb	Active

Related Companies

Authorised Representatives

Insulet Netherlands B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (7)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 18, 2018	Z-0347-2020	—	terminated	There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus history.
Nov 2, 2015	Z-0393-2016	—	terminated	Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
Nov 2, 2015	Z-0394-2016	—	terminated	Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
Jul 13, 2015	Z-2485-2015	—	terminated	OmniPods (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin
Jul 13, 2015	Z-2484-2015	—	terminated	OmniPods (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin
Sep 27, 2013	Z-0165-2014	—	terminated	Alcohol Prep Pads contained within the kit are not properly labeled.
Sep 27, 2013	Z-0166-2014	—	terminated	Alcohol Prep Pads contained within the kit are not properly labeled.