What is FDA product code QFG?

An alternate controller enabled insulin infusion pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient. The ACE insulin pump may include basal and bolus drug delivery at set or variable rates. ACE insulin pumps are designed to reliably and securely communicate with external devices, such as automated insulin dosing systems, to allow insulin delivery commands to be received, executed, and confirmed. ACE insulin pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of insulin delivery.

Omnipod 5 Starter Kit · Alternate Controller Enabled Insulin Infusion Pump → General Hospital

Name: Omnipod 5 Starter Kit
Brand: Omnipod 5 Starter Kit

2manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

5recalls on this code

Who Else Makes It

All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code QFG
Manufacturer	City	Province	Registered as	Device types
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15
Steris Sterilization Technologies (Suzhou) Ltd	Suzhou	Jiangsu	Contract manufacturer	44

Record

Regulatory record for Omnipod 5 Starter Kit
Listed by	Insulet Corporation, United States
FDA product code	QFG
Device type	Alternate Controller Enabled Insulin Infusion Pump
Device class	Class 2
Regulation	21 CFR 880.5730
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
Record published	2024-02-22
Record revised	2024-07-29 (version 2)

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, manufacturing date, serial number
Storage	Storage environment temperature 32 to 86 °F; Storage environment humidity 20 to 90 % RH; Storage environment atmospheric pressure 700 to 1060 KiloPascal

Catalogue Numbers

Catalogue numbers for Omnipod 5 Starter Kit
Catalogue number	Size	Status
SKT-M001-G-X9		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Tandem Mobi Autosoft XC Kit	Tandem Diabetes Care, Inc.	13
t:slim X2 Insulin Pump with Control-IQ+ Technology	Tandem Diabetes Care, Inc.	12
t:slim X2 Insulin Pump with Control-IQ	Tandem Diabetes Care, Inc.	11
t:slim X2 Insulin Pump with Basal-IQ	Tandem Diabetes Care, Inc.	9
Tandem Mobi	Tandem Diabetes Care, Inc.	5
MiniMed Flex	Medtronic Minimed	4
Tandem Mobi Autosoft 30 Kit	Tandem Diabetes Care, Inc.	4
Omnipod 5 Pod	Insulet Corporation	3
Tandem Mobi TruSteel Kit	Tandem Diabetes Care, Inc.	3
Tandem Mobi Cartridge	Tandem Diabetes Care, Inc.	3
MiniMed Flex Starter Kit	Medtronic, Inc.	2
Omnipod 5 Controller APP	Insulet Corporation	2

Showing 12 of 36. All products under Alternate Controller Enabled Insulin Infusion Pump

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K231826	2023-10-18
K203768	2022-01-27
K191679	2019-09-20

Recalls

3 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2026-05-20	Class I	Process design	External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of in	4,936,056 units
2026-03-12	Class I	Process design	Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect res	1,240,115 units
2023-11-30	Class I	Software design	The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does not recognize the error on the bolus calculator s	27000 users
2023-02-28	Class II	Software Design Change	An error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone control users from controlling the Omnipod 5 Automated Insulin Delivery System from their Omnipod 5 App which may cause a delay in the	11,016 users
2022-11-14	Class II	Device Design	The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging port and charging cable are melting, deforming, or discoloring due to heat generated by increased resistance in the Controller port. The exces	129,086

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Omnipod 5 Starter Kit