← Product Code [QFG](/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG) · K250792

# t:slim X2 insulin pump with interoperable technology (K250792)

_Tandem Diabetes Care, Inc. · QFG · Sep 24, 2025 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG/K250792

## Device Facts

- **Applicant:** Tandem Diabetes Care, Inc.
- **Product Code:** [QFG](/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG.md)
- **Decision Date:** Sep 24, 2025
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5730
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry
- **Attributes:** Therapeutic, Pediatric

## Indications for Use

The t:slim X2 Insulin Pump with Interoperable Technology (the Pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The Pump is intended for single patient, home use and requires a prescription. The Pump is indicated for use in individuals 2 years of age and greater.

## Device Story

Ambulatory, battery-operated, rate-programmable infusion pump; delivers insulin subcutaneously. Inputs: user-programmed basal/bolus rates via color touch screen or side button; commands from compatible interoperable automated glycemic controllers (e.g., Basal-IQ, Control-IQ) via Bluetooth. Outputs: insulin delivery; audio/vibratory feedback; status/notifications on pump screen and Tandem t:slim mobile app. Used in home settings by patients or caregivers. Mobile app enables smartphone connectivity, data display, and transmission to Tandem Cloud. Device manages diabetes by automating insulin delivery based on user settings or integrated CGM/controller data. Benefits: precise insulin administration; interoperability with digital health ecosystems.

## Clinical Evidence

Bench testing only. Insulin compatibility and leachable testing performed to validate the addition of Lyumjev U-100 insulin. No new clinical, usability, or software verification/validation testing was required.

## Technological Characteristics

Ambulatory, battery-operated, rate-programmable infusion pump. Includes 3mL disposable insulin cartridge (gamma sterilized), infusion set, and mobile application. Connectivity via Bluetooth. User interface via capacitive color touch screen and physical button. Compatible with NovoLog, Humalog, and Lyumjev U-100 insulins.

## Regulatory Identification

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

## Special Controls

Alternate controller enabled infusion pumps must comply with the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) Evidence demonstrating that device infusion delivery accuracy conforms to defined user needs and intended uses and is validated to support safe use under actual use conditions.
(A) Design input requirements must include delivery accuracy specifications under reasonably foreseeable use conditions, including ambient temperature changes, pressure changes (
*e.g.,* head-height, backpressure, atmospheric), and, as appropriate, different drug fluidic properties.(B) Test results must demonstrate that the device meets the design input requirements for delivery accuracy under use conditions for the programmable range of delivery rates and volumes. Testing shall be conducted with a statistically valid number of devices to account for variation between devices.
(ii) Validation testing results demonstrating the ability of the pump to detect relevant hazards associated with drug delivery and the route of administration (
*e.g.,* occlusions, air in line, etc.) within a clinically relevant timeframe across the range of programmable drug delivery rates and volumes. Hazard detection must be appropriate for the intended use of the device and testing must validate appropriate performance under the conditions of use for the device.(iii) Validation testing results demonstrating compatibility with drugs that may be used with the pump based on its labeling. Testing must include assessment of drug stability under reasonably foreseeable use conditions that may affect drug stability (
*e.g.,* temperature, light exposure, or other factors as needed).(iv) The device parts that directly or indirectly contact the patient must be demonstrated to be biocompatible. This shall include chemical and particulate characterization on the final, finished, fluid contacting device components demonstrating that risk of harm from device-related residues is reasonably low.
(v) Evidence verifying and validating that the device is reliable over the ACE pump use life, as specified in the design file, in terms of all device functions and in terms of pump performance.
(vi) The device must be designed and tested for electrical safety, electromagnetic compatibility, and radio frequency wireless safety and availability consistent with patient safety requirements in the intended use environment.
(vii) For any device that is capable of delivering more than one drug, the risk of cross-channeling drugs must be adequately mitigated.
(viii) For any devices intended for multiple patient use, testing must demonstrate validation of reprocessing procedures and include verification that the device meets all functional and performance requirements after reprocessing.
(2) Design verification and validation activities must include appropriate design inputs and design outputs that are essential for the proper functioning of the device that have been documented and include the following:
(i) Risk control measures shall be implemented to address device system hazards and the design decisions related to how the risk control measures impact essential performance shall be documented.
(ii) A traceability analysis demonstrating that all hazards are adequately controlled and that all controls have been validated in the final device design.
(3) The device shall include validated interface specifications for digitally connected devices. These interface specifications shall, at a minimum, provide for the following:
(i) Secure authentication (pairing) to external devices.
(ii) Secure, accurate, and reliable means of data transmission between the pump and connected devices.
(iii) Sharing of necessary state information between the pump and any digitally connected alternate controllers (
*e.g.,* battery level, reservoir level, pump status, error conditions).(iv) Ensuring that the pump continues to operate safely when data is received in a manner outside the bounds of the parameters specified.
(v) A detailed process and procedure for sharing the pump interface specification with digitally connected devices and for validating the correct implementation of that protocol.
(4) The device must include appropriate measures to ensure that safe therapy is maintained when communications with digitally connected alternate controller devices is interrupted, lost, or re-established after an interruption (
*e.g.,* reverting to a pre-programmed, safe drug delivery rate). Validation testing results must demonstrate that critical events that occur during a loss of communications (*e.g.,* commands, device malfunctions, occlusions, etc.) are handled appropriately during and after the interruption.(5) The device design must ensure that a record of critical events is stored and accessible for an adequate period to allow for auditing of communications between digitally connected devices and to facilitate the sharing of pertinent information with the responsible parties for those connected devices. Critical events to be stored by the system must, at a minimum, include:
(i) A record of all drug delivery
(ii) Commands issued to the pump and pump confirmations
(iii) Device malfunctions
(iv) Alarms and alerts and associated acknowledgements
(v) Connectivity events (
*e.g.,* establishment or loss of communications)(6) Design verification and validation must include results obtained through a human factors study that demonstrates that an intended user can safely use the device for its intended use.
(7) Device labeling must include the following:
(i) A prominent statement identifying the drugs that are compatible with the device, including the identity and concentration of those drugs as appropriate.
(ii) A description of the minimum and maximum basal rates, minimum and maximum bolus volumes, and the increment size for basal and bolus delivery, or other similarly applicable information about drug delivery parameters.
(iii) A description of the pump accuracy at minimum, intermediate, and maximum bolus delivery volumes and the method(s) used to establish bolus delivery accuracy. For each bolus volume, pump accuracy shall be described in terms of the number of bolus doses measured to be within a given range as compared to the commanded volume. An acceptable accuracy description (depending on the drug delivered and bolus volume) may be provided as follows for each bolus volume tested, as applicable: Number of bolus doses with volume that is <25 percent, 25 percent to <75 percent, 75 percent to <95 percent, 95 percent to <105 percent, 105 percent to <125 percent, 125 percent to <175 percent, 175 to 250 percent, and >250 percent of the commanded amount.
(iv) A description of the pump accuracy at minimum, intermediate, and maximum basal delivery rates and the method(s) used to establish basal delivery accuracy. For each basal rate, pump accuracy shall be described in terms of the amount of drug delivered after the basal delivery was first commanded, without a warmup period, up to various time points. The information provided must include typical pump performance, as well as worst-case pump performance observed during testing in terms of both over-delivery and under-delivery. An acceptable accuracy description (depending on the drug delivered) may be provided as follows, as applicable: The total volume delivered 1 hour, 6 hours, and 12 hours after starting delivery for a typical pump tested, as well as for the pump that delivered the least and the pump that delivered the most at each time point.
(v) A description of delivery hazard alarm performance, as applicable. For occlusion alarms, performance shall be reported at minimum, intermediate, and maximum delivery rates and volumes. This description must include the specification for the longest time period that may elapse before an occlusion alarm is triggered under each delivery condition, as well as the typical results observed during performance testing of the pumps.
(vi) For wireless connection enabled devices, a description of the wireless quality of service required for proper use of the device.
(vii) For any infusion pumps intended for multiple patient reuse, instructions for safely reprocessing the device between uses.

## Predicate Devices

- t:slim X2 insulin pump with interoperable technology ([K232380](/device/K232380.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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FDA

U.S. FOOD &amp; DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K250792

B Applicant

Tandem Diabetes Care, Inc.

C Proprietary and Established Names

t:slim X2 insulin pump with interoperable technology

D Regulatory Information

|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  QFG | Class II | 21 CFR 880.5730 – Alternate Controller Enabled Infusion Pump | CH – Clinical Chemistry  |

## E Purpose for Submission:

The purpose of this submission is to add Lyumjev U-100 insulin as a compatible insulin to the labeling of the subject device.

## II Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

B Indication(s) for Use:

The t:slim X2 Insulin Pump with Interoperable Technology (the Pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.

The Pump is intended for single patient, home use and requires a prescription.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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The Pump is indicated for use in individuals 2 years of age and greater.

## C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

You must take off your pump and leave it outside the procedure room if you are going to have any of the following medical procedures: magnetic resonance imaging (MRI), x-ray, computed tomography (CT) scan, positron emission tomography (PET) scan, other exposure to radiation, pacemaker/automatic implantable cardioverter defibrillator (AICD) placement or reprogramming, cardiac catheterization, or nuclear stress test. Always notify the provider/technician about your diabetes and your pump. If you need to discontinue use of the pump for medical procedures, follow your healthcare provider's instructions to replace missed insulin when you reconnect to the pump. Check your BG before disconnecting from the pump and again when you reconnect and treat high BG levels as recommended by your healthcare provider.

Always ensure your pump has established a Bluetooth wireless connection with your smartphone before you use the Tandem t:slim mobile app. Confirm that the information displayed to you matches your signs and symptoms. If the information displayed to you in your Tandem t:slim mobile app does not match your signs and symptoms, always refer to the t:slim X2 insulin pump before making any treatment decisions.

For patients who do not self-manage their disease, the Security PIN function should always be on when the pump is not being used by a caregiver. The Security PIN function is intended to prevent inadvertent screen taps or button presses that may lead to insulin delivery or changes in the pump settings. These changes can potentially lead to hypoglycemia (low BG) or hyperglycemia (high BG) events.

For patients whose insulin administration is managed by a caregiver, always turn off the Quick Bolus feature to avoid inadvertent bolus delivery. If the Security PIN is turned on, the Quick Bolus feature is automatically disabled.

## III Device Description

The t:slim X2 Insulin Pump with Interoperable Technology is an ambulatory, battery operated, rate-programmable infusion pump designed for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The front of the pump includes a color touch screen display that has a capacitive touch panel that detects a finger touch. The Screen On Button on the side of the insulin pump is surrounded by an LED indicator light. This button is used to turn on the touch screen display so that the user can operate their System. The Screen On Button also provides users with a quick bolus option, which is a feature that allows a user to program and deliver a bolus of insulin through a sequence of presses, without using the touch screen. The System provides audio and vibratory feedback to the user to confirm the delivery. In the case of an incomplete sequence, the bolus is canceled.

K250792 - Page 2 of 5

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The t:slim X2 insulin pump with interoperable technology system also includes: the Tandem t:slim mobile application and a 3 mL (300 insulin unit) t:slim X2 cartridge and a compatible FDA cleared infusion set. The Tandem t:slim mobile application ("mobile app") enables a user to connect a smartphone to the pump using Bluetooth® wireless technology to display pump information and perform some pump functions on the smartphone as well as display pump notifications. The Tandem t:slim mobile application can also be used to transmit historical pump and mobile app therapy data to the Tandem Cloud. The t:slim X2 cartridge is a disposable insulin cartridge compatible only with the t:slim X2 pump.

The pump may be used in combination with a compatible continuous glucose monitor (CGM) system. The t:slim X2 pump can be used for basal and bolus insulin delivery with or without a CGM or with a compatible interoperable automated glycemic controller, such as the Basal-IQ Technology or the Control IQ Technology to aid in diabetes management.

## IV Substantial Equivalence Information:

### A Predicate Device Name(s):

t:slim X2 Insulin Pump with Interoperable Technology

### B Predicate 510(k) Number(s):

K232380

### C Comparison with Predicate(s):

|  Device & Predicate Device(s): | K250792 | K232380  |
| --- | --- | --- |
|  Device Trade Name | t:slim X2 insulin pump with interoperable technology | Same  |
|  General Device Characteristic Similarities |  |   |
|  Intended Use/Indications For Use | The t:slim X2 Insulin Pump with Interoperable Technology (the Pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing | Same  |

K250792 - Page 3 of 5

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K250792 - Page 4 of 5

|   | software, to receive, execute, and confirm commands from these devices.

The Pump is intended for single patient, home use and requires a prescription.

The Pump is indicated for use in individuals 2 years of age and greater. |   |
| --- | --- | --- |
|  **General Device Characteristic Differences** |  |   |
|  Compatible Insulins | For Type 1 diabetes mellitus in persons 2 years of age and greater and Type 2 diabetes mellitus in persons 18 years of age and greater:
NovoLog U-100 Insulin
Humalog U-100 Insulin
Lyumjev U-100 Insulin | For Type 1 diabetes mellitus in persons 2 years of age and greater and Type 2 diabetes mellitus in persons 18 years of age and greater:
NovoLog U-100 Insulin
Humalog U-100 Insulin  |

V Standards/Guidance Documents Referenced:

- ANSI AAMI ISO 14971:2019 – “Medical devices - Applications of risk management to medical devices”

VI Performance Characteristics:

A. Analytical Performance

The accuracy in basal delivery, bolus delivery and occlusion detection remain unchanged from the predicate.

B. Other Supportive Instrument Performance Characteristics Data

The sponsor conducted in vitro insulin compatibility testing with Lyumjev U-100 insulin to verify that the pumps and the insulin are compatible. The stability of the insulin product was evaluated under stressed, worst-case conditions. The studies observed acceptable results and support the compatibility of this insulin product with these pumps.

VII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

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K250792 - Page 5 of 5

VIII Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG/K250792](https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG/K250792)

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