LIFEPAK 15 AC Power Adapter (41577-000333)

K253099 · Physio-Control, Inc. · MPD · Oct 14, 2025 · Cardiovascular

Device Facts

• Record ID: K253099
• Device Name: LIFEPAK 15 AC Power Adapter (41577-000333)
• Applicant: Physio-Control, Inc.
• Product Code: MPD · Cardiovascular
• Decision Date: Oct 14, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5300
• Device Class: Class 2

Indications for Use

The LIFEPAK 15 AC power adapter is an optional accessory intended to connect to the LIFEPAK 15 monitor/defibrillator to provide auxiliary power. The bracket and screws provided are intended to attach the power adapter to a wall or shelf. The LIFEPAK 15 AC Power Adapter is intended for the in-hospital environment and ground transport vehicles.

Device Story

Optional accessory for LIFEPAK 15 monitor/defibrillator; provides auxiliary power to operate device with or without batteries; charges internal batteries when installed. Used in in-hospital environments and ground transport vehicles. Attached to wall or shelf via provided bracket and screws. Keeps monitor/defibrillator powered to manage battery charge. No patient-applied parts.

Clinical Evidence

No clinical data (human or animal) submitted. Evidence consists of bench testing, including electrical safety, electromagnetic compatibility (EMC), and design verification testing. All predetermined acceptance criteria were satisfied.

Technological Characteristics

Auxiliary power supply; 100-240 VAC input; 11.0-14.0 VDC output; IP32 dust/water resistance; Class II safety with functional earth. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-12, and IEC 60601-2-4. Non-sterile, reusable.

Indications for Use

Indicated for use as an auxiliary power supply for the LIFEPAK 15 monitor/defibrillator in in-hospital environments and ground transport vehicles.

Regulatory Classification

Identification

Low-energy DC-defibrillator: A device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body. High-energy DC-defibrillator: A device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.

Predicate Devices

• LIFEPAK 35 AC Power Adapter (K240162)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

October 14, 2025

Physio-Control, Inc.
Elisha McGaff
Senior Staff Regulatory Affairs Specialist
11811 Willows Road NE
Redmond, Washington 98052

Re: K253099
Trade/Device Name: LIFEPAK 15 AC Power Adapter (41577-000333)
Regulation Number: 21 CFR 870.5300
Regulation Name: DC-Defibrillator (Including Paddles)
Regulatory Class: Class II
Product Code: MPD
Dated: September 19, 2025
Received: September 24, 2025

Dear Elisha McGaff:

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.

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"

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

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K253099 - Elisha McGaff
Page 2

(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); 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-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).

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K253099 - Elisha McGaff
Page 3

Sincerely,

JENNIFER W. SHIH -S

Jennifer Kozen
Assistant Director
Division of Cardiac Electrophysiology,
Diagnostics, and Monitoring Devices
Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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LIFEPAK 15 AC Power Adapter
Page 7 of 30

| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253099 | ? |
| Please provide the device trade name(s). | | ? |
| LIFEPAK 15 AC Power Adapter (41577-000333) | | |
| Please provide your Indications for Use below. | | ? |
| The LIFEPAK 15 AC power adapter is an optional accessory intended to connect to the LIFEPAK 15 monitor/defibrillator to provide auxiliary power. The bracket and screws provided are intended to attach the power adapter to a wall or shelf. The LIFEPAK 15 AC Power Adapter is intended for the in-hospital environment and ground transport vehicles. | | |
| Please select the types of uses (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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LIFEPAK 15 AC Power Adapter
Special 510(k) K253099
Stryker Emergency Care
11811 Willows Road NE, Redmond, WA 98052 | P [phone] | stryker.com

# 510(K) SUMMARY

## Submitter:

Physio-Control, Inc.
11811 Willows Road Northeast
Redmond, Washington 98052
Registration Number: 3015876, 3006703820

## Contact:

Elisha McGaff
Senior Staff Regulatory Affairs Specialist
425-867-4619 (office)
[e-mail]

Date of Preparation: September 19, 2025

Device Trade/Proprietary Name: LIFEPAK® 15 AC Power Adapter (41577-000333)

Device Common Name: AC Power Adapter (ACPA)

## Device Classification:

| Device Classification and CFR Reference | Classification Panel | Product Code |
| --- | --- | --- |
| Auxiliary power supply (AC or DC) for low-energy DC-Defibrillator (21 CFR 870.5300) | Cardiovascular Devices | MPD |

## Predicate Device(s):

The features and functions of the proposed LIFEPAK 15 AC Power Adapter accessory is equivalent to the following previously cleared device:

| Predicate Device | 510(k) Number(s) / Clearance Date |
| --- | --- |
| LIFEPAK 35 AC Power Adapter | K240162 / Cleared on 04/19/2024 |

Page 1 of 4

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Device Description:

The LIFEPAK 15 AC Power Adapter is an optional accessory meant to be used with only the LIFEPAK 15 monitor/defibrillator. The LIFEPAK 15 AC Power Adapter provides power to operate the monitor/defibrillator with or without batteries installed. Additionally, the LIFEPAK 15 AC Power Adapter provides power to the internal battery charger (installed in the LIFEPAK 15 monitor/defibrillator) to charge the LIFEPAK 15 device's batteries, if they are installed. To help manage and maintain a battery charge, the power adapter should be kept plugged into the monitor/defibrillator whenever possible.

Indications for Use:

The LIFEPAK 15 AC power adapter is an optional accessory intended to connect to the LIFEPAK 15 monitor/defibrillator to provide auxiliary power. The bracket and screws provided are intended to attach the power adapter to a wall or shelf. The LIFEPAK 15 AC Power Adapter is intended for the in-hospital environment and ground transport vehicles.

Summary of Technological Characteristics:

The intended use, features, and functional characteristics of the proposed LIFEPAK 15 AC Power Adapter are equivalent to the predicate device.

The proposed modifications have not raised any new issues of safety and effectiveness when compared to the existing predicate device.

| Characteristic | Predicate Device: LIFEPAK 35 AC Power Adapter | Modified Device: LIFEPAK 15 AC Power Adapter |
| --- | --- | --- |
| Manufacturer | Physio-Control Inc. | Same |
| Trade Name | LIFEPAK 35 AC Power Adapter | LIFEPAK 15 AC Power Adapter |
| 510(k) Number | K240162 | K253099 |
| Device Classification | 2 | 2 |
| Product Code | MPD | Same |
| Regulation Number | 21 CFR 870.5300 | Same |
| Prescription/ Over-the-Counter Use | Prescription | Same |

LIFEPAK 15 AC Power Adapter
Special 510(k) K253099
Stryker Emergency Care
11811 Willows Road NE, Redmond, WA 98052
P [phone]
stryker.com

{6}

| Characteristic | Predicate Device: LIFEPAK 35 AC Power Adapter | Modified Device: LIFEPAK 15 AC Power Adapter |
| --- | --- | --- |
| Indications for Use/ Intended Use | The LIFEPAK 35 AC power adapter is an optional accessory intended to connect to the LIFEPAK 35 monitor/defibrillator to provide auxiliary power. The bracket and screws provided are intended to attach the power adapter to a wall or shelf. The LIFEPAK 35 AC Power Adapter is intended for indoor environments and for fixed installation in ground transportation vehicles. | The LIFEPAK 15 AC power adapter is an optional accessory intended to connect to the LIFEPAK 15 monitor/defibrillator to provide auxiliary power. The bracket and screws provided are intended to attach the power adapter to a wall or shelf. The LIFEPAK 15 AC Power Adapter is intended for the in-hospital environment and ground transport vehicles. |
| Usage | Reusable | Same |
| Sterile | Non-sterile | Same |
| Input Voltage Rating/Frequency | 100-240 VAC
50/60/400 Hz 1.8 A | Same |
| Output Voltage/Amperage | 14.8 to 16.0 Volts 8.6 A DC from 0° to 40°C; at least 6.5 A DC from >40° to 45°C | 11.0 to 14.0 Volts 7 A DC from 0° to 40°C; at least 6.5 A DC from >40° to 45°C |
| Nominal Cable Length | 35.43 inches | 9.331 inches |
| Mating Connector Type for Device Compatibility | Plug in connector compatible with the LIFEPAK 35 monitor/defibrillator | Plug in connector compatible with the LIFEPAK 15 monitor/defibrillator |
| Operating Temperature | 0° to 45°C (32° to 113°F) | Same |
| Non-Operating Temperature | -40° to 70°C (-40° to 158°F) | Same |
| Operating Relative Humidity | 5 to 95%, non-condensing | Same |

LIFEPAK 15 AC Power Adapter
Special 510(k) K253099

Stryker Emergency Care

11811 Willows Road NE, Redmond, WA 98052

P [phone]

stryker.com

{7}

| Characteristic | Predicate Device: LIFEPAK 35 AC Power Adapter | Modified Device: LIFEPAK 15 AC Power Adapter |
| --- | --- | --- |
| Operating Altitude | 795 to 429 mmHG
(-1,253 to 15,000 ft) | Same |
| Non-Operating Altitude | -382 to 5,486 m
(-1253 to 18,000 ft) | Same |
| Dust and Water Resistance | IP32 | Same |
| Safety Class | Class II with a functional earth (FE). No patient-applied parts. | Same |
| Electrical Safety and Performance | IEC60601-1
IEC60601-1-2
IEC60601-1-12
IEC60601-2-4 | Same |

## Performance Data:

Performance testing has been completed to demonstrate that the proposed LIFEPAK 15 AC Power Adapter meets the safety and performance requirements established in the design specifications. Comprehensive testing included the following:

- Electrical Safety and Electromagnetic Compatibility Testing
- Design Verification Testing

No human or animal clinical studies were submitted as part of this 510(k) Premarket Notification.

In summary, the design verification testing was successfully completed, and the predetermined acceptance criteria were satisfied.

## Conclusion:

The information in this 510(k) notification demonstrates that the Physio-Control LIFEPAK 15 AC Power Adapter is substantially equivalent to the predicate LIFEPAK 35 AC Power Adapter with respect to safety, effectiveness, and performance.

LIFEPAK 15 AC Power Adapter
Special 510(k) K253099
Stryker Emergency Care
11811 Willows Road NE, Redmond, WA 98052
P [phone]
stryker.com