Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)
Device Facts
| Record ID | K260394 |
|---|---|
| Device Name | Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) |
| Applicant | Hangzhou Jimushi Meditech Co., Ltd. |
| Product Code | EZD · Gastroenterology, Urology |
| Decision Date | Jun 24, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5130 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
Intermittent urinary catheterization of adult males, females and pediatrics by inserting through the urethra to pass urine from the bladder.
Device Story
Disposable, sterile, hydrophilic-coated intermittent urinary catheter for single-patient use. Device consists of PVC shaft with hydrophilic coating, two drainage eyelets, and color-coded funnel connector. Package includes prefilled purified water and touch-free sleeve for aseptic insertion. Available in straight, coude, or soft-tip configurations. Used by clinicians or patients for bladder drainage. Output is urine flow into collection container. Benefits include reduced friction during insertion and touchless handling to minimize contamination risk.
Clinical Evidence
Bench testing only. Performance verified via ISO 20696:2018 (dimensions, strength, flow rate, connector security, anti-kinking), YY-0325:2022 (bending resistance), ISO 11070:1998 (coating adhesion), and EN868-5:2009 (seal strength). Biocompatibility testing performed per ISO 10993 series (cytotoxicity, sensitization, irritation, systemic toxicity, implantation, genotoxicity). Sterilization validated per ISO 11137-2:2013.
Technological Characteristics
PVC shaft with PVP hydrophilic coating; 8-18 Fr size range; straight, coude, or soft-tip options. Sterilized via Gamma radiation. Packaging: aluminum foil. Connectivity: none. Energy source: none (manual).
Indications for Use
Indicated for intermittent urinary catheterization of adult males, females, and pediatrics (older than 2 years) to drain urine from the bladder. Contraindications: acute urethritis, acute prostatitis, acute epididymitis, PVC or gel allergy, menstruation, and calcareous urolithiasis.
Regulatory Classification
Identification
A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).
Predicate Devices
- Jimushi Sterile Urethral Catheter for single use-Hydrophilic coated with water pocket model (K200134)
Submission Summary (Full Text)
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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 24, 2026
Hangzhou Jimushi Meditech Co., Ltd.
% Wei-Shan Hsu
Regulatory Manager
Vee Care Asia Limited
9f-25, # 188, Sec. 4, Chenggong Rd., Neihu Dist.,
Taipei, 114049
TAIWAN
Re: K260394
Trade/Device Name: Hydrophilic coated intermittent nalaton catheter for single
use-ready to use (NCR)
Regulation Number: 21 CFR 876.5130
Regulation Name: Urological Catheter and accessories
Regulatory Class: II
Product Code: EZD
Dated: May 22, 2026
Received: May 22, 2026
Dear Wei-Shan Hsu:
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: The Center for Devices and Radiological Health (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, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K260394 - Wei-Shan Hsu
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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).
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
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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).
Sincerely,
JESSICA K. NGUYEN -S
Jessica K. Nguyen, Ph.D.
Assistant Director
DHT3B: Division of Reproductive,
Gynecology, and Urology Devices
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. | K260394 | ? |
| --- | --- | --- |
| Please provide the device trade name(s). | | ? |
| Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) | | |
| Please provide your Indications for Use below. | | ? |
| Intermittent urinary catheterization of adult males, females and pediatrics by inserting through the urethra to pass urine from the bladder. | | |
| 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) | ? |
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K260394
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# K260394 510(k) Summary
### 1. Date Prepared
June 24, 2026
### 2. Submitter's Information
Name of Sponsor: Hangzhou Jimushi Meditech Co.,Ltd.
Address: Bldg. 1, No. 12 Longtan Rd., Cangqian St., Yuhang Dist., Hangzhou, Zhejiang Prov., P.R. China
Contact Name: Fenlong Wu
Telephone No.: +86-571-85857559
### 3. Trade Name, Common Name, Classification
Trade Name: Hydrophilic coated intermittent nalaton catheter for single use-ready to use
Regulation classification name: Urological Catheter and accessories
Regulation number: 21 CFR 876.5130
Product code: EZD
Device Class: Class II
### 4. Identification of Predicate Device(s)
K200134 Jimushi Sterile Urethral Catheter for single use-Hydrophilic coated with water pocket model
### 5. Description of the Device
Hydrophilic-coated intermittent catheters for single use-ready to use, is a disposable sterile catheter intended for insertion through the urethra to the bladder for urine drainage. The target users are children (older than 2 years), women, and men.
The catheter body is made of polyvinyl chloride (PVC) with hydrophilic coating. The distal end may have a straight tip, coude tip, or soft tip, and includes two eyelets for efficient drainage. At the proximal end, there is a funnel-shaped, color-coded connector that can be attached to a urine collection container. The
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K260394
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package is prefilled with purified water and with a touch-free sleeve for easy grip, enabling touchless insertion.
The product is packaged in aluminum foil and sterilized by Gamma radiation.
## 6. Indication for Use
Intermittent urinary catheterization of adult males, females and pediatrics by inserting through the urethra to pass urine from the bladder.
## 7. Similarities and Differences of the Proposed Devices to the Predicate Devices
The Hydrophilic coated intermittent nalaton catheter for single use-ready to use is substantially equivalent to the predicate device, Jimushi Sterile Urethral Catheter for single use (K200134) in that these devices have same intended use and technological characteristics. 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. The differences between the subject device and predicate device do not affect the basic design principle and usage.
A detailed comparison to the predicate is provided in Table 1.
| | Subject Device | Predicate Device | Similarities and Differences |
| --- | --- | --- | --- |
| Manufacturer | Hangzhou Jimushi Meditech Co.,Ltd. | Hangzhou Jimushi Meditech Co.,Ltd. | |
| Trade Name | Hydrophilic coated intermittent nalaton catheter for single use-ready to use | Jimushi Sterile Urethral Catheter for single use-Hydrophilic coated with water pocket model | |
| 510(k) number | N/A | K200134 | -- |
| Device Class | Class II | Class II | Same |
| Product Code | EZD | GBM | FDA product code change |
| Device classification Name | Urological Catheter and Accessories | Urological Catheter and Accessories | Same |
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K260394
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| Regulation number | 876.5130 | 876.5130 | Same |
| --- | --- | --- | --- |
| Indications for Use | Intermittent urinary catheterization of adult males, females and pediatrics by inserting through the urethra to pass urine from the bladder | Intermittent urinary catheterization by inserting through the urethra to pass urine from the bladder. | Same |
| Contraindications | -Acute urethritis -Acute prostatitis -Acute epididymitis -Patients with PVC or Gel allergy -Patients are in menstrual period -Patients have calcareous urolithiasis | -Acute urethritis -Acute prostatitis -Acute epididymitis -Patients with PVC or Gel allergy -Patients are in menstrual period -Patients have calcareous urolithiasis | Same |
| Population | Male, Female and Pediatric | Male, Female and Pediatric | Same |
| Size range | 8-18 Fr. | 8-18 Fr. | Same |
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K260394
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| Effective shaft length | Fr | Effective length (mm) | Fr | Effective length (mm) | Different^{1} |
| --- | --- | --- | --- | --- | --- |
| | 08 10 | Male,Straight:343±15 Male, Coude: 337±15 Male, Soft tip: 330±15 Female,Straight:96±15 Female, Soft tip: 95±15 Pediatric, Straight: 196±15 Pediatric,Coude:192±15 Pediatric, Soft tip: 195±15 | 08 10 | Male,Straight:343±3 Male, Coude: 337±3 Female:141±3 Pediatric: 241±3 | |
| | 12 14 16 18 | Male,Straight: 337±15 Male, Coude: 333±15 Male, Soft tip: 330±15 Female,Straight:92±15 Female, Soft tip: 95±15 Pediatric,Straight: 192±15 Pediatric,Coude:190±15 Pediatric, Soft tip: 195±15 | 12 14 16 18 | Male,Straight: 337±3 Male, Coude: 333±3 Female:137±3 Pediatric: 237±3 | |
| Shaft | Tubular | | Tubular | | Same |
| Shaft Material | PVC | | PVC | | Same |
| Coating | Hydrophilic (PVP) | | Hydrophilic (PVP) | | Same |
| Tip | Straight, Coude and Soft-tip | | Straight and Coude | | Different^{2} |
| Eyelets | Yes | | Yes | | Same |
| Biocompatibility | ISO10993-5 Cytotoxicity ISO 10993-10 Sensitization ISO 10993-10 Penile irritation ISO 10993-11 Acute systemic Toxicity, | | ISO10993-5 Cytotoxicity ISO 10993-10 Sensitization ISO 10993-10 Penile irritation | | Different^{3} |
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| | Subchronic systemic Toxicity, pyrogen test ISO 10993-6 Implantation test ISO 10993-3 Bacterial Reverse Mutation Assay, Chromosome Aberration Assay | | |
| --- | --- | --- | --- |
| Primary Packaging | Aluminum foil | Dialysis paper and plastic film | Different^{4} |
| Single use | Yes | Yes | Same |
| Sterile | Yes | Yes | Same |
| Sterilization | Gamma irradiation | Ethylene Oxide | Different^{5} |
### 8. Justification for the differences
According to the comparison table, the subject device when compared to the predicate device differs in the effective shaft length, additional tip configuration, sterile barrier packaging material and the sterilization method. To address differences, non-clinical testing was conducted to support the substantial equivalence of the subject device.
### 9. Non-clinical Performance Data
The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
| Testing Performed | Reference to Standard | Results |
| --- | --- | --- |
| ID and OD | ISO 20696:2018 | Pass |
| Eyelets dimensions | NA | Pass |
| Product length | ISO 20696:2018 | Pass |
| Strength | ISO 20696:2018 | Pass |
| Peak tensile force | ISO 20696:2018 | Pass |
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| Air tightness | N/A | Pass |
| --- | --- | --- |
| Flow Rate | ISO 20696:2018 | Pass |
| Bending resistance | YY-0325:2022 | Pass |
| Connector security | ISO 20696:2018 | Pass |
| Adhesion of coating | ISO 11070:1998 | Pass |
| Lubricity of coating | N/A | Pass |
| Water volume | N/A | Pass |
| Performance and Dimensions of the double-sided adhesive | N/A | Pass |
| Anti-kinking performance | ISO 20696:2018 | Pass |
| Coating appearance | N/A | Pass |
| Coating length | N/A | Pass |
| Sealing edge width | EN868-5:2009 | Pass |
| Seal Strength | EN868-5:2009 | Pass |
| Budding test | ASTM F2096-11 | Pass |
| Biocompatibility Testing | ISO 10993-5:2009 ISO 10993-10:2021 ISO 10993-11:2017 ISO 10993-23:2021 ISO 10993-6:2016 ISO 10993-3:2014 | Pass |
| Sterilization | ISO 11137-2:2013/Amd.1 2022 | Pass |
Overall, the results are comparable to the predicate and support a determination of substantial equivalence.
## 10. Conclusion
The Hydrophilic coated intermittent nalaton catheter for single use-ready to use has the same intended use and similar technological characteristics as the predicate. Both the subject and predicate devices are intended for same patient populations-
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K260394
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male, female and pediatric. Both the subject and predicate devices are disposable, sterile, single patient use devices. The predicate device has not been subject to a design-related recall.
The differences in technological characteristics between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. We concluded that Hydrophilic coated intermittent nalaton catheter for single use-ready to use is substantially equivalent to the predicate device.
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