SOL-M Luer Lock Syringe with Exchangeable Needle Tray
Device Facts
| Record ID | K252184 |
|---|---|
| Device Name | SOL-M Luer Lock Syringe with Exchangeable Needle Tray |
| Applicant | Sol-Millennium Medical, Inc. |
| Product Code | FMF · General Hospital |
| Decision Date | Aug 25, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5860 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Luer Lock Syringe with Exchangeable Needle Tray is used to inject fluids into, or withdraw fluids from, the body.
Device Story
Sterile, single-use 3-piece piston syringe with detachable pre-attached needle; used for manual injection or withdrawal of fluids. System comprises syringe barrel, plunger, Isoprene rubber piston, and exchangeable needle; components made of polypropylene. Available in 3, 5, and 10mL volumes with 20-23G needle options. Operated manually by medical professionals in clinical settings. Packaged in bulk thermal-formed plastic trays with Tyvek sterile-barrier material. Output is the delivery or aspiration of fluids; device facilitates medication administration or fluid sampling. Benefits include sterile, single-use delivery mechanism for clinical procedures.
Clinical Evidence
No clinical data. Bench testing only, including biocompatibility (ISO 10993-1), package integrity (visual, seal strength, dye penetration), sterility (USP <71>), endotoxin (EP 10.2.6.14), and simulated transportation (ISTA-3A:2018).
Technological Characteristics
Materials: Polypropylene (barrel/plunger/hub/cap), Isoprene rubber (piston), SUS 304 (needle). Manual operation. Luer lock connector (ISO 80369-7). Sterilization: EtO (SAL 10^-6). Packaging: Bulk plastic tray with Tyvek sterile barrier. Standards: ISO 7864, ISO 9626, ISO 11607-1, ASTM F88/F88-15, ASTM F1929-15.
Indications for Use
Indicated for medical professionals for the injection of fluids into, or withdrawal of fluids from, the body. Prescription use only.
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
- Luer Lock Syringe with Exchangeable Needle (K241821)
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG
ADMINISTRATION
August 25, 2026
Sol-Millennium Medical, Inc.
Mike Xie
VP of QA/RA
311 S Wacker Dr.
Suite 4100
Chicago, Illinois 60606
Re: K252184
Trade/Device Name: SOL-M Luer Lock Syringe with Exchangeable Needle Tray
Regulation Number: 21 CFR 880.5860
Regulation Name: Piston Syringe
Regulatory Class: Class II
Product Code: FMF, FMI
Dated: July 20, 2026
Received: August 3, 2026
Dear Mike Xie:
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
{1}
K252184 - Mike Xie
Page 2
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).
{2}
K252184 - Mike Xie
Page 3
Sincerely,
**SHRUTI N. MISTRY -S**
Shruti Mistry, M.S.
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
{3}
| 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. | K252184 | ? |
| Please provide the device trade name(s). | | ? |
| SOL-M Luer Lock Syringe with Exchangeable Needle Tray | | |
| Please provide your Indications for Use below. | | ? |
| The Luer Lock Syringe with Exchangeable Needle Tray is used to inject fluids into, or withdraw fluids from, the body. | | |
| 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) | ? |
{4}
**SolM**Building^{}[] ^{}[] a Healthier^{}[] ^{}[] Tomorrow
# 510(k) Summary
### 1. Preparation date: August 25, 2026
### 2. Submitter
Manufacturer: Sol-Millennium Medical Inc.
Address: 311 S. Wacker Dr, Suite 4100 Chicago, IL 60606, United States
Contact person: Mike Xie, VP of QA/RA, +1 847-400-4821, yxie@solm.com
### 3. Device
Trading name: SOL-M Luer Lock Syringe with Exchangeable Needle Tray
Regulation No.: 21 CFR § 880.5860; 21 CFR § 880.5570
Classification name: Syringe, Piston; Needle, Hypodermic, Single Lumen
Classification: Class II
Product code: FMF; FMI
Review panel: General Hospital
### 4. Predicate device
510(k) Number: K241821
Trading name: Luer Lock Syringe with Exchangeable Needle
Regulation No.: 21 CFR § 880.5860; 21CFR 880.5570
Classification name: Syringe, Piston, Antistick, Needle, Hypodermic, Single Lumen
Classification: Class II
Product code: FMF; MEG; FMI
Review panel: General Hospital
### 5. Device description
This sterile, single-use 3-piece piston syringe features a detachable pre-attached needle for manual use. The system includes multiple syringes with exchangeable needles in a bulk tray. Each unit consists of a needle cap, tube, hub, barrel, plunger, and Isoprene rubber piston, with polypropylene barrel and plunger components. Available in 3, 5, and 10mL volumes with 20-23G needle options and Luer lock connector. The device is packaged in a thermal-formed plastic tray protected with a Tyvek sterile-barrier material, sterilized with EO gas, and offers a 5-year shelf life.
The device is for medical professionals use only and for prescription use only.
1
{5}
SolM Building a Healthier Tomorrow
Table 1. Device specifications
| 3ml Luer Lock Syringe w/Exch Needle Tray 21G*1" |
| --- |
| 3ml Luer Lock Syringe w/Exch Needle Tray 22G*1" |
| 3ml Luer Lock Syringe w/Exch Needle Tray 23G*1" |
| 5ml Luer Lock Syringe w/Exch Needle Tray 20G*1" |
| 5ml Luer Lock Syringe w/Exch Needle Tray 21G*1" |
| 10ml Luer Lock Syringe w/Exch Needle Tray 20G*1" |
| 10ml Luer Lock Syringe w/Exch Needle Tray 21G*1" |
## 6. Indications for use/Intended use
The Luer Lock Syringe with Exchangeable Needle Tray is used to inject fluids into, or withdraw fluids from, the body.
## 7. Comparison of technological characters between proposed and predicate devices
Table 2. Characters comparison
| Element of Comparison | Predicate Device Luer Lock Syringe with exchangeable needle (K241821) | Subject Device SOL-M Luer Lock Syringe with Exchangeable Needle Tray |
| --- | --- | --- |
| **Product Code** | FMF, FMI | FMF, FMI |
| **Intended Use/ Indications for Use** | The Syringe with exchangeable needle is used to inject medicines and vaccines into, or withdraw fluids from, the body. | The Luer Lock Syringe with Exchangeable Needle Tray is used to inject fluids into, or withdraw fluids from, the body. |
2
{6}
**SolM**Building a Healthier Tomorrow
| Element of Comparison | Predicate Device Luer Lock Syringe with exchangeable needle (K241821) | Subject Device SOL-M Luer Lock Syringe with Exchangeable Needle Tray |
| --- | --- | --- |
| | | Same, Different phrases that convey the same meaning. |
| **Principle of Operation** | Manual | Same |
| **Source of Energy** | Manual | Same |
| **Needle/Syringe Connection** | ISO 80369-7 | Same |
| **Needle physical performance** | ISO 7864 ISO 9626 | Same |
| **Device Specifications** | Syringe volume: 1ml, 3ml, 5ml, 10ml Needle gauge: 20G, 21G, 22G, 23G, 25G Needle length: 1', 5/8', 11/2' | Syringe volume: 3ml, 5ml and 10ml Needle gauge: 20G, 21G, 22G, 23G Needle length: 1' Same, within scope. |
| **Device Configuration** | Syringe - Barrel: PP - Plunger: PP - Gasket: IR rubber - Lubricant: silicone oil | Same |
3
{7}
**SolM**Building^{}[] ^{}[] a Healthier^{}[] ^{}[] Tomorrow
| Element of Comparison | Predicate Device Luer Lock Syringe with exchangeable needle (K241821) | Subject Device SOL-M Luer Lock Syringe with Exchangeable Needle Tray |
| --- | --- | --- |
| | Needle - Needle hub: PP - Needle cap: PP - Needle: SUS 304 - Adhesive: Glue | |
| **Packaging Method** | Individual packaging, Tyvek pouch like | Bulk packaging, plastic tray sealed with a Tyvek sterile-barrier material. Different, new packaging types were applied, packaging integrity and sterility testing results verified its effectiveness. So, difference didn't raise any risk, demonstrating the substantial equivalence. |
| **Sterilization** | EtO SAL 10^{-6} | Same |
| **Biocompatibility** | Meet ISO 10993 | Same |
## 8. Non-clinical testing
Non-clinical tests, and sterilization validation were conducted under K241821 with no changes except to the packaging type.
Biocompatibility testing was re-conducted according to the guidance of Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
4
{8}
SolM Building a Healthier Tomorrow
Package integrity testing (including visual inspection, Seal strength, Dye penetration, and Clean peel) had been conducted on simulated transportation treated products. In addition, package testing had been conducted after aging.
Tyvek is used as the sterile barrier material for the package, and the package integrity was tested by the following methods:
- Visual Check: Internal standard
- Clean peel: ISO 11607-1:2019
- Seal strength: ASTM F88/F88-15
- Dye penetration: ASTM F1929-15
- Sterility: USP <71>
- Endotoxin: European Pharmacopoeia 10.2.6.14.
- Simulated transportation: ISTA-3A:2018
Additionally, Bacterial Aerosol Challenge Testing was conducted to validate the suitability of the syringe inside the tray to maintain a sterile barrier after tray opening.
## 9. Clinical testing
Not applicable for this submission.
## 10. Conclusion
The differences between the predicate and the proposed device do not raise any new or different questions of safety or effectiveness. The proposed device is substantially equivalent to the predicate device with respect to indications for use and technological characteristics.
5
