Promisemed X-Safety Pen Needle
Device Facts
| Record ID | K261719 |
|---|---|
| Device Name | Promisemed X-Safety Pen Needle |
| Applicant | Promisemed Hangzhou Meditech Co., Ltd. |
| Product Code | FMI · General Hospital |
| Decision Date | Aug 25, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 880.5570 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
Promisemed X-safety pen needle is intended for use with needle based injector for the injection of drugs.
Device Story
Single-use, double-ended, sterile needle for needle-based injection systems (NISs); compatible with ISO 11608-1 specifications. Device features stainless-steel needle tube with threaded plastic hub; includes passive needle shielding safety mechanisms at patient-end or both patient/cartridge-ends to prevent needle stick injuries. Used in home environments and professional healthcare facilities by lay persons or healthcare professionals for subcutaneous drug delivery. Device is provided sterile; lubricated; single-use only. Healthcare providers use device to facilitate drug administration; safety features reduce accidental injury risk.
Clinical Evidence
Bench testing only. No clinical data. Performance verified against ISO 9626, ISO 7864, ISO 11608-2, and ISO 23908 standards, covering physical, mechanical, biological, chemical, and packaging performance.
Technological Characteristics
Materials: XSCrNi18-10 stainless steel (needle), ABS (trigger), PP (container). Sensing/Actuation: Passive safety mechanism. Energy: None. Dimensions: 29G-32G; 4mm-8mm lengths. Connectivity: None. Sterilization: EO (SAL 10^-6). Standards: ISO 7864, ISO 9626, ISO 11608-2, ISO 23908, ISO 10993.
Indications for Use
Indicated for use with needle-based injectors for drug injection in patients of all ages, including neonates, infants, children, adolescents, and adults.
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
- Promisemed X-Safety Pen Needle (K220129)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG
ADMINISTRATION
August 25, 2026
Promisemed Hangzhou Meditech Co., Ltd.
Zearou Yang
Regulatory Affairs Manager
#1388 Cangxing St., Cangqian Community, Yuhang District
Hangzhou, 311121
China
Re: K261719
Trade/Device Name: Promisemed X-Safety Pen Needle
Regulation Number: 21 CFR 880.5570
Regulation Name: Hypodermic Single Lumen Needle
Regulatory Class: Class II
Product Code: FMI
Dated: August 13, 2026
Received: August 13, 2026
Dear Zearou Yang:
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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K261719 - Zearou Yang
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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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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# 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. | | K261719 | ? |
| --- | --- | --- | --- |
| Please provide the device trade name(s). | | | ? |
| Promisemed X-Safety Pen Needle | | | |
| Please provide your Indications for Use below. | | | ? |
| Promisemed X-safety pen needle is intended for use with needle based injector for the injection of drugs. | | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) | | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☑ Neonates/Newborns (Birth to < 29 days old) ☑ Infants (29 days old to < 2 years old) ☑ Children (2 years old to < 12 years old) ☑ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | | ? |
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Promisemed
Promisemed Hangzhou Meditech Co., Ltd.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, P. R. China.
# K261719-510(k) Summary
Date prepared: 2026-08-21
| **1. Manufacturer [21 CFR 807.92 (a) (1)]** | |
| --- | --- |
| Name | Promisemed Hangzhou Meditech Co., Ltd. |
| Address | No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, China. |
| Contact Person | Zearou Yang |
| Phone | +86 571 88772985 |
| Email | zearou.yang@promisemed.ca |
| **2. Device [21 CFR 807.92 (a) (2)]** | |
| Name | Promisemed X-Safety Pen Needle |
| Common Name | X-Safety Pen Needle |
| Classification Name | Hypodermic Single Lumen Needle |
| Regulation Number | 21 CFR 880.5570 |
| Class | Class II |
| Product Code | FMI |
| **3. Legally Marketed Predicate Device [21 CFR 807.92 (a) (3)]** | |
| Predicate Name | Promisemed X-Safety Pen Needle |
| 510(k) Number | K220129 |
| Product Code | FMI |
| Reference Devices | No reference devices were used in this submission. |
| **4. Device Description [21 CFR 807.92 (a) (4)]** | |
| Promisemed X-Safety Pen Needle is a single-use, double-ended, sterile needle for needle-based injection systems (NISs) that fulfill the specifications of ISO 11608-1. This device is constructed as a double-ended, stainless-steel needle of various sizes that is with a threaded plastic hub. The device includes needle shielding safety features (at both patient-end and cartridge-end or at patient-end only) to reduce the risk of needle stick injury and its container can be provided as short or long type. It is packaged in a sealed sterility barrier, and the needle is lubricated. This is a single-use device and delivered sterile. Sterilization process is validated according to EN ISO 11135. Sterilization process undergoes routine control. | |
| **5. Indication for use [21 CFR 807.92 (a) (5)]** | |
| Promisemed X-safety pen needle is intended for use with needle based injector for the injection of drugs. | |
| **6. Comparison of Technological Characteristic [21 CFR 807.92 (a) (6)]** | |
| The subject device has the same technological characteristics (design, material, chemical composition, principle of | |
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Promisemed
®
Promisemed Hangzhou Meditech Co., Ltd.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, P. R. China.
operation, etc.) as the predicate device. The safety feature is passive, same as predicate device. Size and shape of container is same as predicate device. The differences between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. We concluded the subject device is substantially equivalent to the identified predicate device.
| Item of description | Predicate device (K220129) | | | Subject device (K262719) | | | Similar/ Difference | Safety / Effectiveness Statement |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Common name | X-Safety Pen Needle | | | X-Safety Pen Needle | | | N/A | / |
| Manufacturer | Promisemed Hangzhou Meditech Co., Ltd. | | | Promisemed Hangzhou Meditech Co., Ltd. | | | Same | All produced by the same manufacturer. |
| Intended use /Indications | Promisemed X-safety pen needle is intended for use with needle-based injector for the injection of drugs. | | | Promisemed X-safety pen needle is intended for use with needle-based injector for the injection of drugs. | | | Same | No new concerns |
| Target population | General use | | | General use | | | Same | No new concerns |
| Anatomical site | Subcutaneous tissue | | | Subcutaneous tissue | | | Same | No new concerns |
| Where used | Home Environment, Professional Healthcare Facility | | | Home Environment, Professional Healthcare Facility | | | Same | No new concerns |
| Intended users | Lay person, Healthcare professional users | | | Lay person, Healthcare professional users | | | Same | No new concerns |
| Structure | Example of representative type A | | | Example of representative type A | | | Same | No new concerns. |
| Materials (tissue-contacting) | Components | Material | Contact type | Components | Material | Contact type | Same | No new concerns. |
| | Needle tube | XSCrNi18-10 | Direct contact with tissue | Needle tube | XSCrNi18-10 | Direct contact with tissue | | |
| | Trigger | Acrylonitrile Butadiene Styrene (ABS) | Intact skin | Trigger | Acrylonitrile Butadiene Styrene (ABS) | Intact skin | | |
| | Container | Polypropylene (PP) | Intact skin | Container | Polypropylene (PP) | Intact skin | | |
| Needle gauge | 29G, 30G, 31G, 32G. | | | 29G, 30G, 31G, 32G. | | | Same | No new concerns. |
| Needle length | 4mm, 5mm, 6mm, 8mm | | | 4mm, 5mm, 6mm, 7mm, 8mm. | | | Difference | No new concerns. Subject device has additional needle length (7mm) than predicate device for clinical selection. It does not introduce new risks about effectiveness and safety because that the technical characteristic and operation method is same with the predicate device. |
| Sterilization method | EO sterilization | | | EO sterilization | | | Same | No new concerns |
| Sterility | SAL of \( 10^{-6} \) | | | SAL of \( 10^{-6} \) | | | Same | No new concerns |
| Single use | Yes | | | Yes | | | Same | No new concerns |
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Promisemed
®
Promisemed Hangzhou Meditech Co., Ltd.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, P. R. China.
| Biocompatibility | Compiled with ISO10993 series standards, and the following tests are performed- Cytotoxicity: No cytotoxicity;- Skin Irritation: No evidence of skin irritation;- Skin Sensitization: No evidence of sensitization;- Acute Systemic Toxicity: No systemic toxicity;- Hemolysis: No evidence of hemolysis;- Pyrogen: Non pyrogenic; | Compiled with ISO10993 series standards, and the following tests are performed- Cytotoxicity: No cytotoxicity;- Skin Irritation: No evidence of skin irritation;- Skin Sensitization: No evidence of sensitization;- Acute Systemic Toxicity: No systemic toxicity;- Hemolysis: No evidence of hemolysis;- Pyrogen: Non pyrogenic; | Same | No new concerns |
| --- | --- | --- | --- | --- |
| Standards met | Compiled with ISO 7864, ISO 9626, ISO 11608-2; | Compiled with ISO 7864, ISO 9626, ISO 11608-2; | Same | No new concerns |
| Compatibility with other devices | It is in conjunction with needle-based injection systems (e.g. pen injectors). | It is in conjunction with needle-based injection systems (e.g. pen injectors). | Same | No new concerns |
| Compatibility with the environment | No specific requirements. | No specific requirements. | Same | No new concerns |
| Energy used and/or delivered | None. | None. | Same | No new concerns |
| Electrical safety | N/A. | N/A. | / | / |
| Mechanical safety | N/A. | N/A. | / | / |
| Chemical safety | N/A. | N/A. | / | / |
| Thermal safety | N/A. | N/A. | / | / |
| Radiation safety | N/A. | N/A. | / | / |
The following changes were identified between the subject and predicate devices:
- Added needle length (7mm): Subject device has additional needle length (7mm) than predicate device for clinical selection. It does not introduce new risks about effectiveness and safety because the technical characteristics and operation method are the same as the predicate device.
The subject device has the same intended use and technological characteristics as the predicate device. The basic technological and operating principles are the same for both devices. Both the subject and predicate devices are disposable, sterile, single patient use devices. As evidenced by comparison table above, the subject device is substantially equivalent to the predicate device.
## 7. Non-Clinical and/or Clinical Tests Summary & Conclusions [21 CFR 807.92 (b) (1)]
The subject device meets all the requirements for overall design and performance. Performance testing confirms that the output meets the design inputs and specifications. Internal verification and validation testing confirms that product specifications are met, which support the intended use and technological characteristics as compared to the predicate devices. The information supports the substantial equivalence to the referenced predicate device.
| Test items | | Standard reference |
| --- | --- | --- |
| Physical performance | Needle tubing materials | ISO 9626:2016, clause 4 |
| | Surface finish | ISO 9626:2016, clause 5.2 |
| | Cleanliness | ISO 9626:2016, clause 5.2 |
| | Stiffness | ISO 9626:2016, clause 5.8 |
| | Resistance to breakage | ISO 9626:2016, clause 5.9 |
| | Resistance to corrosion | ISO 9626:2016, clause 5.10 |
| | Penetration force | ISO 7864:2016, Annex D |
| | Dimensions | ISO 9626:2016, clause 5.5 to 5.6; ISO 11608-2:2022, clause 5.2.3 |
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Promisemed
Promisemed Hangzhou Meditech Co., Ltd.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, P. R. China.
| | Flow rate through the needle | ISO 11608-2:2022, clause 5.2.6.1 |
| --- | --- | --- |
| | Bond between hub and needle tube | ISO 11608-2:2022, clause 5.2.7 |
| | Needle points | ISO 11608-2:2022, clause 5.2.4 |
| | Freedom from defects | ISO 11608-2:2022, clause 5.2.5 |
| | Lubrication | ISO 11608-2:2022, clause 5.2.5 |
| | Dislocation of patient end | ISO 11608-2:2022, clause 5.2.8 |
| | Needle container embedding force | ISO 11608-2:2022, clause 5.3 |
| | Ease of assembly | ISO 11608-2:2022, clause 5.2.9 and 5.3.3 |
| | Functional compatibility with NISs | ISO 11608-2:2022, clause 5.3 |
| | Ease of disassembly | ISO 11608-2:2022, clause 5.2.9 and 5.3.3 |
| | Needle container embedding force | Internal requirement JCQ-Q-146 |
| | Accidental access to a sharp once in safe mode | ISO 23908:2024, clause 5.1.5 |
| | Safety mechanism activation | ISO 23908:2024, clause 6 |
| | Safety overriding and unlocking force after activation | ISO 23908:2024, clause 6 |
| Biological performance | Sterility | USP <71> |
| | Bacterial endotoxin | USP <161> |
| Chemical performance | Limits for acidity and alkalinity | ISO 9626:2016, clause 5.4 |
| | Total content of heavy metals | ISO 7864:2016, clause 4.5 |
| | Residual ethylene oxide | ISO 10993-7:2026, clause 4.3.2 |
| Packaging performance | Packaging appearance | ISO 11608-2:2022, clause 10 |
| | Seal strength | ISO 11607-1:2019 |
| | Penetration test | ISO 11607-1:2019 |
#### 8. Conclusion [21 CFR 807.92 (b) (3)]
Based on the nonclinical performance testing described above, the Promisemed X-Safety Pen Needle (subject device) has been demonstrated to be substantially equivalent to the predicate device (K220129). The subject device has the same intended use as the predicate device. While certain technological differences exist (needle length), these differences do not raise different questions of safety and effectiveness when compared to the predicate device. Therefore, the subject device is substantially equivalent to the predicate device.
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