Chrysalis Intelligence · Product Codes · QFG

QFG · Alternate Controller Enabled Insulin Infusion Pump

Clinical Chemistry · 26 clearances · 9 unique sponsors

Device class
Class II
Regulation 880.5730
Total clearances
26
2020-06-04 → 2026-06-17
Last 12 months
7
Unique sponsors
9
Definition

What is Alternate Controller Enabled Insulin Infusion Pump

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.
Medical specialty
Clinical Chemistry
Review panel
CH
Regulation number
880.5730
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Tandem Diabetes Care, Inc. 9 2 2025-11-06
Beta Bionics, Inc. 4 2 2026-04-30
Deka Research and Development 4 1 2026-06-17
Medtronic Minimed, Inc. 3 2 2026-03-12
Insulet Corporation 2 0 2023-10-18
Roche Diabetes Care GmbH 1 0 2023-08-10
Embecta Medical I, LLC 1 0 2024-08-30
Triple Jump Israel , Ltd. 1 0 2023-12-20
Deka Research & Development Corp. 1 0 2025-04-02
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
E1591 HCPCS High Insulin infusion pump with alternate controller capability
E1592 HCPCS Automatic intermittent peritoneal dialysis system ✓ CMS-verified description High Insulin infusion pump without integrated glucose monitoring
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-17 K261672 Deka Research and Development twiist Automated Insulin Delivery (AID) System
2026-04-30 K253976 Beta Bionics, Inc. iLet ACE Pump
2026-03-12 K253743 Medtronic Minimed, Inc. MiniMed Flex pump
2026-01-15 K253470 Medtronic Minimed, Inc. MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)
2025-11-06 K253074 Tandem Diabetes Care, Inc. Tandem Mobi insulin pump with interoperable technology
2025-09-29 K252770 Beta Bionics, Inc. iLet ACE Pump
2025-09-24 K250792 Tandem Diabetes Care, Inc. t:slim X2 insulin pump with interoperable technology
2025-07-01 K251032 Medtronic Minimed, Inc. MiniMed 780G insulin pump
2025-04-02 K250930 Deka Research & Development Corp. twiist system
2024-08-30 K234027 Embecta Medical I, LLC embecta Insulin Delivery System
2024-07-26 K241078 Tandem Diabetes Care, Inc. Tandem Mobi Insulin Pump with interoperable technology
2024-05-24 K241178 Deka Research and Development DEKA ACE Pump System
2024-03-21 K240309 Tandem Diabetes Care, Inc. Tandem Mobi insulin pump with interoperable technology
2024-03-13 K233952 Deka Research and Development DEKA ACE Pump System
2023-12-20 K230545 Triple Jump Israel , Ltd. Inessa System
2023-11-03 K232380 Tandem Diabetes Care, Inc. t:slim X2 Insulin Pump with Interoperable Technology
2023-10-18 K231826 Insulet Corporation Omnipod 5 ACE Pump
2023-10-05 K233044 Tandem Diabetes Care, Inc. Tandem Mobi insulin pump with interoperable technology
2023-08-10 K213134 Roche Diabetes Care GmbH Accu-Chek Solo micropump system with interoperable technology
2023-07-25 K213536 Deka Research and Development DEKA ACE Pump System
2023-07-10 K223213 Tandem Diabetes Care, Inc. Tandem Mobi Insulin Pump with Interoperable Technology
2023-06-21 K231485 Beta Bionics, Inc. iLet® ACE Pump
2023-05-19 K223846 Beta Bionics, Inc. iLet® ACE Pump
2022-02-15 K203234 Tandem Diabetes Care, Inc. t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)
2022-01-27 K203768 Insulet Corporation Omnipod 5 ACE Pump (Pod)