t:slim X2 insulin pump with interoperable technology

K250792 · Tandem Diabetes Care, Inc. · QFG · Sep 24, 2025 · Clinical Chemistry

Device Facts

• Record ID: K250792
• Device Name: t:slim X2 insulin pump with interoperable technology
• Applicant: Tandem Diabetes Care, Inc.
• Product Code: QFG · Clinical Chemistry
• Decision Date: Sep 24, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5730
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Indications for Use

Indicated for individuals 2 years of age and older with diabetes mellitus requiring insulin for subcutaneous delivery at set and variable rates.

Regulatory Classification

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)

Submission Summary (Full Text)

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FDA U.S. FOOD &amp; DRUG ADMINISTRATION

September 24, 2025

Tandem Diabetes Care, Inc.
Miriam Chan
Principal Regulatory Affairs Specialist
12400 High Bluff Drive
San Diego, California 92130

Re: K250792
Trade/Device Name: t:slim X2 insulin pump with interoperable technology
Regulation Number: 21 CFR 880.5730
Regulation Name: Alternate Controller Enabled Infusion Pump
Regulatory Class: Class II
Product Code: QFG
Dated: March 14, 2025
Received: August 26, 2025

Dear Miriam Chan:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

U.S. Food &amp; Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K250792 - Miriam Chan
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

JOSHUA BALSAM -S

Joshua M. Balsam, Ph.D.
Branch Chief
Division of Chemistry and
Toxicology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K250792

Device Name
t:slim X2 insulin pump with interoperable technology

Indications for Use (Describe)
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.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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TANDEM

Diabetes Care

# 510(k) Summary

| Company | Tandem Diabetes Care, Inc
12400 High Bluff Drive
San Diego, CA 92130 |
| --- | --- |
| Prepared | March 07, 2025 |
| Contact | Miriam Chan
Principal Regulatory Affairs Specialist
[e-mail]
[phone] |
| Trade Name | t:slim X2 insulin pump with interoperable technology |
| Common Name | Alternate controller enabled infusion pump |
| Classification Product Code | QFG |
| Classification Name | Alternate controller enabled infusion pump |
| Regulation Number | 21 CFR 880.5730 |
| Device Class | Class II |
| Predicate Device | K232380, t:slim X2 insulin pump with interoperable technology |

# I. Device Under Review

The Subject Device, t:slim X2 insulin pump with interoperable technology ("t:slim X2 insulin pump", "the pump") is an 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.

The t:slim X2 insulin pump with interoperable technology system also includes: the Tandem t:slim mobile application and a 3mL (300 insulin unit) t:slim X2 cartridge and a compatible FDA cleared infusion set. The Tandem

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TANDEM

Diabetes Care

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 will also be used to transmit historical pump and mobile app therapy data to the Tandem Cloud. The Tandem t:slim mobile application will be made available via the Apple® App Store for iOS compatible smartphones and the Android Play Store for Android compatible smartphones based on completed device verification and validation. The t:slim X2 cartridge is a disposable insulin cartridge compatible only with the t:slim X2 pump.

The t:slim X2 pump can be used for basal and bolus insulin delivery with or without a CGM or with any compatible interoperable automated dosing algorithm.

The pump may be used in combination with a compatible continuous glucose monitor (CGM) system. Use of CGM is optional.

## II. 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 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.

Technological Characteristics Compared to Predicate Device K232380

| | Predicate Device (K232380) | Subject Device |
| --- | --- | --- |
| Intended Use/Indication 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, | Identical |

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Diabetes Care

| | 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. | |
| --- | --- | --- |
| Prescription Use | Yes | Identical |
| Classification | 21 CFR 880.5730 | Identical |
| Product Code | QFG | Identical |
| Technological Characteristics | 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 device includes a disposable cartridge which is motor driven to deliver patient programmed basal rates and boluses through an infusion set into subcutaneous tissue. | Identical |
| Principles of Operation | Delivery of insulin (Bolus and Basal) programmed by the user based on health care provider recommendations. | Identical |
| Compatible Insulins | Type 1 diabetes mellitus in persons 2 years of age and greater Type 2 diabetes mellitus in persons 18 years of age and greater:
NovoLog U-100 Insulin
Humalog U-100 Insulin | Type 1 diabetes mellitus in persons 2 years of age and greater Type 2 diabetes mellitus in persons 18 years of age and greater:
NovoLog U-100 Insulin
Humalog U-100 Insulin
Lyumjev U-100 Insulin |
| System General Components | + Infusion Pump
+ Mobile Application
+ Single-use, Sterile Disposable Insulin Cartridge | Identical |
| Cartridge Sterilization Method | Gamma Sterilization | Identical |

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Diabetes Care

| Pump Type | ACE pump, t:slim X2 insulin pump with interoperable technology | Identical |
| --- | --- | --- |
| Accessories | + Compatible Infusion Sets
+ Power Supply
+ Belt Clip | Identical |

## IV. Overview of Non-Clinical and Clinical Performance Tests

Insulin compatibility and leachable testing was performed to support this 510(k) Notification. The outcome of the insulin compatibility and leachable testing demonstrates that the Subject Device is as safe and as effective as the Predicate Device.

### Usability/Human Factors:

No new Usability/Human Factors testing was performed to support this 510(k) Notification.

### Software Verification and Validation:

No new software testing was performed to support this 510(k) Notification.

### Special Controls:

Evaluation and adherence to the Special Controls of the Predicate Device (K232380) demonstrates continued assurance of the safety and effectiveness of the Subject Device.

### Conclusion:

The Subject Device has the same intended use and indications as the Predicate Device. Furthermore, the testing demonstrated that Lyumjev is a compatible insulin with t:slim X2 insulin pump with interoperable technology. The required technical documentation provided in this 510(k) demonstrates the Subject Device is as safe and as effective as the Predicate Device. Therefore, the Subject Device has been evaluated to be substantially equivalent to the Predicate Device and does not raise new or different questions of safety or effectiveness.