Omnipod Go Insulin Delivery Device 35u/day
Catalogue number POD-INS-I1-3525, listed by Insulet Corporation, United States, under Pump, Infusion, Insulin. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
1catalogue number
13510(k) clearances naming this product code
14recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Guangdong (3), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Providence Enterprise Limited | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Advance Technology Ltd | Shenzhen | Guangdong | Contract manufacturer | 3 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Viant Medical Suzhou EPZ Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Insulet Corporation, United States |
|---|---|
| FDA product code | LZG |
| Device type | Pump, Infusion, Insulin |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K223372 |
| Record published | 2023-08-18 |
| Record revised | 2025-12-04 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | 5 pack box of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| POD-INS-I1-3525 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OneTouch Ping | Animas Corp. | 12 |
| Easy Release | Sooil Development Co., Ltd. | 9 |
| V-Go Disposable Insulin Delivery | Mannkind Corporation | 6 |
| Accu-Chek Combo | Roche Diabetes Care, Inc. | 5 |
| Superline | Sooil Development Co., Ltd. | 4 |
| t:slim Cartridge, t:lock, 10 Pack | Tandem Diabetes Care, Inc. | 3 |
| Dana Diabecare | Sooil Development Co., Ltd. | 3 |
| Accu-Chek Spirit Cartridge | Roche Diabetes Care, Inc. | 2 |
| t:slim X2 Insulin Pump | Tandem Diabetes Care, Inc. | 2 |
| Omnipod | Insulet Corporation | 2 |
| Soft-Release-ST | Sooil Development Co., Ltd. | 2 |
| t:slim Insulin Pump, Replacement | Tandem Diabetes Care, Inc. | 1 |
Showing 12 of 53. All products under Pump, Infusion, Insulin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223372 | 2023-04-24 |
| K211575 | 2021-08-13 |
| K192659 | 2019-10-21 |
| K182630 | 2019-01-08 |
| K180045 | 2018-06-01 |
| K162296 | 2017-04-18 |
| K160252 | 2016-04-27 |
| K140439 | 2014-11-13 |
| K131294 | 2013-08-29 |
| K122953 | 2012-12-07 |
| K111669 | 2011-12-15 |
| K042792 | 2005-01-03 |
| K031373 | 2003-12-19 |
Recalls
7 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.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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 | 1,790,784 units | |
| 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 | 289,046 units | |
| 2022-10-17 | Class I | Device Design | The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire hazard. The firm has received a complaint alleging fire as a result of thermal energ | 248,288 US; 167,802 OUS | 2024-09-17 |
| 2021-02-01 | Class II | Labeling design | Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and hypoglycemia. Only Outside the US (OUS): Error in the Omnipod DASH User Guide text, page 6 of the User Guide, the text states that the comma | 21,723 guides | 2023-02-08 |
| 2020-04-02 | Class II | Device Design | After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct amout of IOB before suggesting a bolus amount. | 400 | 2021-09-14 |
| 2020-04-02 | Class II | Device Design | After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct amout of IOB before suggesting a bolus amount. | 1773 | 2021-09-14 |
| 2020-02-13 | Class II | Software design | In certain scenarios, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old when the user does not exit the bolus calculator as designed or when a system alarm interrupt | 32756 (US), 1420 (International) | 2021-09-14 |
| 2018-12-18 | Class II | Software design | 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. | 264 | 2020-05-13 |
| 2015-11-02 | Class I | Process change control | Pod’s needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism. | 5,179.0 boxes | 2017-03-07 |
| 2015-11-02 | Class I | Process change control | Pod’s needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism. | 26,230.9 boxes | 2017-03-07 |
| 2015-07-13 | Class I | Nonconforming Material/Component | 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 | 24829 boxes Expanded: 26,230.9 boxes | 2017-01-26 |
| 2015-07-13 | Class I | Nonconforming Material/Component | 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 | 16,017 boxes. Expanded Recall: 5,179.0 boxes | 2017-01-26 |
| 2013-09-27 | Class II | Labeling design | Alcohol Prep Pads contained within the kit are not properly labeled. | 5,050 kits | 2014-03-04 |
| 2013-09-27 | Class II | Labeling design | Alcohol Prep Pads contained within the kit are not properly labeled. | 1,719 starter kits | 2014-03-04 |
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.