Pivot Insulin Pump Replacement
The Pivot Replacement Insulin Pump is the reusable delivery component of the Pivot Insulin Delivery System for adults aged 18 years and older with diabetes who require insulin. It provides…
The Pivot Replacement Insulin Pump is the reusable delivery component of the Pivot Insulin Delivery System for adults aged 18 years and older with diabetes who require insulin. It provides programmed basal delivery and user-selected bolus doses through the system’s compatible disposable cartridge and infusion set.
A software-controlled gear motor rotates a camshaft that drives pistons in the insulin cartridge. This moves insulin through the fluid pathway to the infusion set’s subcutaneous cannula. Redundant sensors monitor delivery, with alarms for malfunctions, occlusions and low insulin volume.
Listed Item
Box of one (1) replacement Pump (software version v2.X)
Compatible Insulin and Setup
The system is compatible with Humalog U-100 insulin. The separate Pivot Diabetes App configures and sends the basal schedule to the pump. The disposable cartridge supplies power, and the pump requires the integrated infusion set for delivery to the patient.
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 | Modular Medical, United States |
|---|---|
| FDA product code | LZG |
| Device type | Pump, Infusion, Insulin |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K253534 |
| Record published | 2026-05-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment humidity 15 to 90 % RH; Storage environment temperature -4 to 140 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Pivot Insulin Delivery System | 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 |
|---|---|
| K262153 | 2026-09-02 |
| K253534 | 2026-04-08 |
| K240158 | 2024-09-04 |
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.