PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)
Device Facts
| Record ID | K252098 |
|---|---|
| Device Name | PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) |
| Applicant | Methyl Co., Ltd. |
| Product Code | MEG · General Hospital |
| Decision Date | Feb 18, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5860 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
This product is designed for medical applications, specifically to administer injections or extract body fluids. It can be used to inject drug solutions into tissues or aspirate body fluids. To prevent the possibility of needle pricks, the safety device can be engaged to secure the injection needle within a removable outer sleeve.
Device Story
PA3X Detachable Safety Sleeve Syringe is a sterile, single-use manual piston syringe with an integrated hypodermic needle and a manually activated safety mechanism. Device components include a polypropylene barrel, plunger, needle hub, and detachable outer sleeve, plus a stainless steel needle and rubber gasket. Used by healthcare professionals for fluid injection or aspiration. Following use, the operator manually advances the outer sleeve to lock over the needle, providing post-use sharps protection and reducing needlestick injury risk. The device is supplied sterile via ethylene oxide. It is available in 3mL and 5mL volumes with a 23G x 1-inch needle. The device functions as a standard manual syringe with an added safety feature to protect the user after the procedure.
Clinical Evidence
No clinical data. Substantial equivalence is supported by bench testing, including performance testing per ISO 7886-1, ISO 7864, ISO 9626, ISO 23908, and ISO 80369-7. Biocompatibility testing (cytotoxicity, irritation, sensitization, systemic toxicity, hemolysis) and pyrogen testing (USP <151>, <85>) confirm safety. Sterilization validation (ISO 11135) and shelf-life stability (ASTM F1980) were also performed.
Technological Characteristics
Materials: Polypropylene (barrel, plunger, hub, sleeve), stainless steel (needle), rubber (gasket). Sensing/Actuation: Manual piston operation with manual safety sleeve activation. Energy: None (manual). Dimensions: 3mL/5mL, 23G x 1" needle. Connectivity: None. Sterilization: Ethylene oxide. Standards: ISO 7886-1 (syringe), ISO 7864/9626 (needle), ISO 80369-7 (luer), ISO 23908 (sharps protection).
Indications for Use
Indicated for patients requiring injection of drug solutions into tissues or aspiration of body fluids. No specific age or gender contraindications stated.
Regulatory Classification
Identification
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.
Predicate Devices
- TERUMO® SurGuard® 3 Hypodermic Syringe with Safety Needle (K113422)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
February 18, 2026
Methyl Co., Ltd.
Stephanie Hsieh
Assistant Manager
7F.-2, No. 1, Guangfu S. Rd.
Taipei, 105
Taiwan
Re: K252098
Trade/Device Name: PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)
Regulation Number: 21 CFR 880.5860
Regulation Name: Piston Syringe
Regulatory Class: Class II
Product Code: MEG, FMI
Dated: January 16, 2026
Received: January 16, 2026
Dear Stephanie Hsieh:
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).
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K252098 - Stephanie Hsieh
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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 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and 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 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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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K252098 - Stephanie Hsieh
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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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| 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) K252098 | |
| Device Name PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) | |
| Indications for Use (Describe) This product is designed for medical applications, specifically to administer injections or extract body fluids. It can be used to inject drug solutions into tissues or aspirate body fluids. To prevent the possibility of needle pricks, the safety device can be engaged to secure the injection needle within a removable outer sleeve. | |
| 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) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
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510(k) SUMMARY – K252098
Prepared in accordance with 21 CFR 807.92
I. Submitter Information
Submitter: Methyl Co., Ltd.
Address: 7F-2, No.1, Kuang-Fu South Road, Taipei 105, Taiwan
Contact Person: Stephanie Hsieh
Date Prepared: February 13, 2026
510(k) Number: K252098
Type of Submission: Traditional 510(k)
II. Device Identification
Trade Name: PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)
Common Name: Safety Syringe with Needle
Classification Name: Piston Syringe; Hypodermic Single Lumen Needle
Regulation Numbers: 21 CFR 880.5860; 21 CFR 880.5570
Regulatory Class: Class II
Product Codes: MEG; FMI
III. Predicate Device
Primary Predicate Device: TERUMO® SurGuard® 3 Hypodermic Syringe with Safety Needle
510(k) Number: K113422
Regulation Numbers: 21 CFR 880.5860; 21 CFR880.5570
Product Codes: MEG; FMI
IV. Device Description
The PA3X Detachable Safety Sleeve Syringe is a sterile, single-use manual piston syringe with an integrated hypodermic needle and a manually activated safety mechanism intended to reduce the risk of needlestick injuries following use.
The device consists of:
- Polypropylene barrel
- Polypropylene plunger
- Rubber gasket
- Polypropylene needle hub
- Stainless steel needle
- Needle cap
- Polypropylene detachable outer sleeve safety mechanism
Following injection or aspiration, the outer sleeve is manually advanced to cover and lock over the needle to provide post-use sharps protection.
The device is available in:
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- $3\mathrm{mL}$ (23G × 1-inch needle)
- $5\mathrm{mL}$ (23G × 1-inch needle)
The device is sterilized using ethylene oxide and supplied sterile for single use.
# V. Indications for Use
This product is designed for medical applications, specifically to administer injections or extract body fluids. It can be used to inject drug solutions into tissues or aspirate body fluids. To prevent the possibility of needle pricks, the safety device can be engaged to secure the injection needle within a removable outer sleeve.
The intended use of the subject device is the same as that of the predicate device.
VI. Comparison of Technological Characteristics
| Characteristic | Subject Device | Primary Predicate Device (K113422) | Same/Different |
| --- | --- | --- | --- |
| Manufacturer | Methyl Co., Ltd. | TERUMO (PHILIPPINES) CORPORATION | N/A |
| Product Name | PA3X Detachable Safety Sleeve Syringe | TERUMO® SurGuard®3 Hypodermic Syringe with Safety Needle | N/A |
| Model Number | SC-23ED, SD-23ED | SG3-series (multiple models) | N/A |
| K Number | K252098 | K113422 | N/A |
| Regulation Number | 21 CFR 880.5860; 21 CFR 880.5570 | 21 CFR 880.5570; 21 CFR 880.5860 | Same |
| Product Code | MEG, FMI | MEG, FMI | Same |
| Indications for Use | This product is designed for medical applications, specifically to administer injections or extract body fluids. It can be used to inject drug solutions into tissues or aspirate body fluids. To prevent the possibility of needle pricks, the safety device can be engaged to secure the injection needle within a removable outer sleeve. | The TERUMO SURGuard®3 Safety Needle device is intended for use in the aspiration and injection of fluids for medical purposes. The TERUMO SurGuard®3 Safety Needle is compatible for use with standard luer slip and luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety | Same |
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| | | shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick | |
| --- | --- | --- | --- |
| Configuration | Barrel, plunger, gasket, needle hub, needle cap, injection needle, outer sleeve | Barrel, plunger, gasket, needle cap, needle tube, needle hub, sheath lock | Different |
| Syringe Volume | 3mL, 5mL | 3mL, 5mL, 10mL | Different |
| Connection Type | Luer Slip | Luer Slip and Luer Lock | Different |
| Needle Gauge | 23G | 18G, 20G, 21G, 22G, 23G, 25G | Different (subset) |
| Needle Length | 1" | 1", 1½", 2" | Different (subset) |
| Needle Wall Type | Regular wall | Thin wall | Different |
| Materials: Needle Cap | PP | PP | Same |
| Materials: Safety Mechanism Component | Outer sleeve (PP) | Sheath lock (PP) | Different (design); Same (material) |
| Materials: Injection Needle | SUS 304 Stainless Steel | Stainless Steel | Same |
| Materials: Needle Hub | PP | PP | Same |
| Materials: Barrel | PP | PP | Same |
| Materials: Gasket | Rubber | Rubber | Same |
| Materials: Plunger | PP | PP | Same |
| DEHP/PVD/BPA Free | Yes | Yes | Same |
| Latex Free | Yes | Yes | Same |
| Sterilization Method | Ethylene Oxide (EO) | Radiation | Different |
| Shelf Life | 3 years | 5 years | Different |
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| Performance Standards: Syringe Performance | ISO 7886-1:2017 | ISO 7886-1:2017 | Same |
| --- | --- | --- | --- |
| Performance Standards: Needle Performance | ISO 7864:2016; ISO 9626:2016 | ISO 7864:2016; ISO 9626:2016 | Same |
| Performance Standards: Luer Connector | ISO 80369-7:2021 | ISO 80369-7:2021 | Same |
| Performance Standards: Sharps Protection | ISO 23908:2024 | ISO 23908 | Same |
| Biocompatibility: Cytotoxicity | No cytotoxicity (ISO 10993-5) | No cytotoxicity | Same |
| Biocompatibility: Irritation | No intracutaneous reactivity (ISO 10993-23) | No intracutaneous reactivity | Same |
| Biocompatibility: Sensitization | No sensitization (ISO 10993-10) | No sensitization | Same |
| Biocompatibility: Systemic Toxicity | No systemic toxicity (ISO 10993-11) | No systemic toxicity | Same |
| Biocompatibility: Hemolysis | No hemolysis (ISO 10993-4) | No hemolysis | Same |
| Biocompatibility: Pyrogen | No pyrogen (USP <151>, <85>) | No pyrogen | Same |
## VII. Discussion of Differences
### Indications for Use
The subject device Indications for Use statement contains minor wording differences compared to the predicate device; however, both devices are intended for the aspiration and injection of fluids for medical purposes with an integrated safety mechanism to reduce needlestick injuries. Both devices are classified under the same regulations and product codes. The wording differences do not alter the fundamental intended use and do not raise new questions of safety and effectiveness when compared to the predicate device.
### Safety Mechanism Design
The subject device utilizes a detachable outer sleeve safety mechanism, whereas the predicate device employs a hinged sheath lock mechanism. Although the mechanical configurations differ, both designs provide manually activated post-use needle coverage and are constructed of similar polymeric materials. Performance testing conducted in accordance with recognized sharps injury protection
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standards demonstrates effective needle shielding and activation reliability. The difference in safety mechanism design does not alter the intended use or fundamental protective function and does not raise new questions of safety and effectiveness when compared to the predicate device.
## Syringe Volume
The subject device is available in 3 mL and 5 mL volumes, whereas the predicate device includes an additional 10 mL configuration. The subject device volumes represent a subset of the predicate device's available configurations. Performance testing conducted in accordance with ISO 7886-1 demonstrates compliance with dimensional accuracy, leakage resistance, and functional performance requirements. This difference does not raise new questions of safety and effectiveness when compared to the predicate device.
## Connection Type
The subject device is available with a Luer Slip connection only, while the predicate device offers both Luer Slip and Luer Lock configurations. The subject device has been evaluated for compliance with ISO 80369-7 requirements for small-bore connectors. The absence of a Luer Lock option represents a subset configuration and does not alter the intended use or raise new questions of safety and effectiveness when compared to the predicate device.
## Needle Specifications
The subject device is available in a 23G × 1-inch configuration, whereas the predicate device includes additional gauge and length options. The subject device specifications fall within the predicate device's available range. Testing conducted in accordance with ISO 7864 and ISO 9626 demonstrates compliance with applicable dimensional and mechanical requirements. These differences represent a subset of the predicate configurations and do not raise new questions of safety and effectiveness when compared to the predicate device.
## Sterilization Method
The subject device is sterilized using ethylene oxide, while the predicate device is sterilized using radiation. Ethylene oxide sterilization has been validated in accordance with ISO 11135 to achieve a sterility assurance level of 10⁻⁶. Both sterilization methods are recognized for single-use sterile medical devices. This difference does not raise new questions of safety and effectiveness when compared to the predicate device.
## Shelf Life
The subject device demonstrates a 3-year shelf life, compared to the predicate device's 5-year shelf life. The shelf-life claim is supported by stability and aging studies conducted in accordance with applicable standards. The shorter shelf life does not raise new questions of safety and effectiveness when compared to the predicate device.
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VIII. Non-Clinical Testing
Testing demonstrates compliance with the following recognized standards:
Performance Standards
- ISO 7886-1:2017 – Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
- ISO 7864:2016 – Sterile hypodermic needles for single use — Requirements and test methods
- ISO 9626:2016 – Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
- ISO 23908:2024 – Sharps injury protection — Requirements and test methods
- ISO 80369-7:2021 – Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
Biocompatibility Standards
- ISO 10993-1:2018 – Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
- ISO 10993-5 – Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
- ISO 10993-4 – Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
- ISO 10993-10 – Biological evaluation of medical devices — Tests for skin sensitization
- ISO 10993-23 – Biological evaluation of medical devices — Tests for irritation
- ISO 10993-11 – Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
Sterilization and Shelf-Life Standards
- ISO 11135:2014 – Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
- ASTM F1980 – Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- USP <85> – Bacterial Endotoxins Test
- USP <151> – Pyrogen Test
- USP <788> – Particulate Matter in Injections
Testing demonstrated compliance with applicable requirements.
IX. Conclusion
The subject device has the same intended use and fundamental scientific technology as the predicate device (K113422). Identified differences in safety mechanism design, available configurations, sterilization method, and shelf life have been evaluated through appropriate testing and do not raise new questions of safety or effectiveness when compared to the predicate device.
The PA3X Detachable Safety Sleeve Syringe is substantially equivalent to the predicate device.
