MOWANA™ Auto Duo

K261266 · PENTAMASTER MEDIQ SDN BHD · FMI · Sep 17, 2026 · General Hospital

Device Facts

• Record ID: K261266
• Device Name: MOWANA™ Auto Duo
• Applicant: PENTAMASTER MEDIQ SDN BHD
• Product Code: FMI · General Hospital
• Decision Date: Sep 17, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Indications for Use

The hypodermic pen needle is intended to be used with pen injector device for subcutaneous injection of medications including but not limited to insulin. The device has a passive dual safety mechanism that activates to cover both ends of the pen needle upon use to prevent accidental needle stick injuries.

Device Story

Disposable, sterile, single-use hypodermic pen needle; attaches to standard pen injectors for subcutaneous medication delivery. Features passive dual-ended safety mechanism; shields both patient-side and pen-side needle tips post-injection to prevent accidental needlestick injuries. Operated by healthcare professionals or patients in clinical or home settings. Mechanical design utilizes housing, needle cover, compression spring, retainer, shield, pivot, torsion spring, and slider. Upon injection, safety shields deploy and lock automatically. Benefits include reduced risk of sharps injury for users and caregivers. Available in 31G gauge with 4mm, 5mm, 6mm, and 8mm lengths.

Clinical Evidence

Bench testing only. Included functional performance per ISO 11608-2:2022, ISO 9626:2016, ISO 7864:2016, ISO 23908:2011, and biocompatibility per ISO 10993-1:2018. Summative usability validation (simulated clinical use) conducted with 30 evaluators across six pen injectors; safety mechanism performed as intended. Confidence-Reliability engineering validation achieved 99.80% confidence at 99% reliability (619/619 samples passed).

Technological Characteristics

Materials: stainless steel needle, polypropylene housing/hub. Energy: mechanical (spring-loaded). Dimensions: 31G; 4mm, 5mm, 6mm, 8mm lengths. Sterilization: Ethylene Oxide (EtO). Standards: ISO 11608-2:2022, ISO 9626:2016, ISO 7864:2016, ISO 23908:2011, ISO 10993-1:2018.

Indications for Use

Indicated for subcutaneous injection of medications (e.g., insulin) via pen injector devices in patients requiring such therapy. Suitable for both professional and home use.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• BD AutoShield Duo (K223286)

Submission Summary (Full Text)

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September 17, 2026

PENTAMASTER MEDIQ SDN BHD
% Dave Yungvirt, CEO
Third Party Review Group, LLC
1887 Whitney Mesa Dr. Suite 1960,
Henderson, NV 89014 USA

Re: K261266

Trade/Device Name: MOWANA™ Auto Duo
Regulation Number: 21 CFR 880.5570
Regulation Name: Hypodermic Single Lumen Needle
Regulatory Class: Class II
Product Code: FMI
Dated: August 12, 2026
Received: August 12, 2026

Dear Dave Yungvirt:

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" (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).

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

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K261266 - Dave Yungvirt

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Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 Management System Regulation (QMSR) (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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K261266 - Dave Yungvirt

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Sincerely,

**SHRUTI N. MISTRY -S**

Shruti Mistry

Assistant Director

DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors

OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices

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.

510(k) Number (if known)
K261266

Device Name
MOWANA™ Auto Duo

Indications for Use (Describe)

The hypodermic pen needle is intended to be used with pen injector device for subcutaneous injection of medications including but not limited to insulin.

The device has a passive dual safety mechanism that activates to cover both ends of the pen needle upon use to prevent accidental needle stick injuries.

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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FORM FDA 3881 (8/23)

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| 510(k) #: K261266 | 510(k) Summary | Prepared on: 2026-09-01 |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | PENTAMASTER MEDIQ SDN BHD | |
| Applicant Address | PMT 861, Persiaran Cassia Selatan 6 Simpang Ampat Pulau Pinang 14110 Malaysia | |
| Applicant Contact Telephone | [phone] | |
| Applicant Contact | Mr. Thean Lye Ong | |
| Applicant Contact Email | [e-mail] | |
| Correspondent Name | PENTAMASTER MEDIQ SDN BHD | |
| Correspondent Address | PMT 861, Persiaran Cassia Selatan 6 Simpang Ampat Pulau Pinang 14110 Malaysia | |
| Correspondent Contact Telephone | [phone] | |
| Correspondent Contact | Ms. Nurzainuriza Zainol | |
| Correspondent Contact Email | [e-mail] | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | MOWANA™ Auto Duo | |
| Common Name | Hypodermic single lumen needle | |
| Classification Name | Needle, Hypodermic, Single Lumen | |
| Regulation Number | 880.5570 | |
| Product Code(s) | FMI | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K223286 | BD AutoShield Duo | FMI |
| Device Description Summary | | 21 CFR 807.92(a)(4) |
| MOWANA™ Auto Duo is a disposable single use sterile device used in conjunction with pen needle injection devices for injecting medication under the skin. It has a passive dual safety mechanism that activates to cover both ends of the pen needle upon use to prevent accidental needle stick injuries. It is available in four variants, namely the G31×4mm, G31×5mm, G31×6mm and G31×8mm variants which has different needle effective lengths (4mm, 5mm, 6mm and 8mm). The device has a housing which contains the needle used for injection. The housing has a standard thread that attaches to pen needle injection devices. It also houses the needle cover, compression spring and retainer which forms the pen-side safety mechanism. The housing is assembled into the shield together with the pivot, torsion spring and slider to form the patient-side safety mechanism. The hypodermic pen needle is sealed securely inside the container with a paper cover. It is sterilized using ethylene oxide (ETO). | | |

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# Intended Use/Indications for Use

21 CFR 807.92(a)(5)

The hypodermic pen needle is intended to be used with pen injector device for subcutaneous injection of medications including but not limited to insulin. The device has a passive dual safety mechanism that activates to cover both ends of the pen needle upon use to prevent accidental needle stick injuries.

# Indications for Use Comparison

21 CFR 807.92(a)(5)

The exact statements of intended use or indications for use for MOWANA™ Auto Duo differ from the predicate device (BD AutoShield™ Duo, K223286). Although the wording differs, both devices are intended for use with pen injector devices for subcutaneous administration of medication and incorporate dual-ended safety features intended to reduce needlestick injuries.

The differences are editorial in nature and therefore do not constitute a new intended use, nor does it raise any new questions of safety and effectiveness when compared to the predicate device.

# Technological Comparison

21 CFR 807.92(a)(6)

MOWANA™ Auto Duo has the same technological characteristics as the predicate device (BD AutoShield™ Duo, K223286) with respect to intended use, safety mechanism concept, device classification, device category, contact type/duration, sterility, and the majority of component materials (e.g., stainless steel needle/cannula, polypropylene housing/hub).

Identified technological differences are: (1) two additional needle lengths (4mm, 6mm) and one less gauge size (30G not offered); (2) a different principle of operation — while both devices employ passive dual-ended sharps protection and follow the same overall operational sequence, the internal mechanical design used to deploy and lock the safety shields differs; (3) alternate resins for select components (shield, slider, needle cover) and two components (pivot, retainer) unique to the subject device's mechanism; (4) differing scope of disclosed biocompatibility testing, with all core endpoints required for this device's category and contact duration evaluated for the subject device; and (5) a different terminal sterilization method (ethylene oxide vs. gamma irradiation).

The finished device has been evaluated through verification, validation, functional, biocompatibility, and (for principle of operation) simulated clinical use testing to successfully meet all requirements. Therefore, the identified technology differences do not raise new questions of safety or effectiveness when compared to the predicate device.

# Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

The subject device has the same intended use and core design as the predicate device cleared under K223286, with the technological differences identified above. Pentamaster MediQ has validated the design of the subject device as part of its design control process in accordance with the Quality System Regulation. This testing included functional performance per ISO 11608-2:2022, ISO 9626:2016, ISO 7864:2016, ISO 23908:2011, as well as Biocompatibility testing per ISO 10993-1:2018.

A Summative Usability Validation Study (Simulated Clinical Use), per FDA guidance "Medical Devices with Sharps Injury Prevention Features" (Section 10), was also conducted with 30 evaluators (healthcare professionals and home users) across six commercial pen injectors. The safety mechanism did not impede clinical performance, activate prematurely, or fail to protect against sharps injury prior to disposal, with all acceptance criteria met. This was supported by device-level Confidence-Reliability engineering validation (99.80% confidence, 99% reliability; 619/619 samples passed).

Not applicable

All non-clinical tests passed successfully – the subject device met all functional and biocompatibility requirements and is shown to be as safe, as effective and performs as well as the predicate device. The non-clinical tests have demonstrated that the subject device is substantially equivalent to the predicate device.