BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit
Device Facts
| Record ID | K254076 |
|---|---|
| Device Name | BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit |
| Applicant | C.R. Bard, Inc. |
| Product Code | FCM · Gastroenterology, Urology |
| Decision Date | May 29, 2026 |
| Decision | SESK |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5130 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The BD Touchless™ Plus Unisex Urethral Catheter Kit is indicated for intermittent catheterization of the urethra to drain urine from the bladder by adult patients who are not capable of voluntary urination.
Device Story
Device is a sterile, single-use, pre-lubricated red rubber intermittent urethral catheter kit; includes urine collection bag, gloves, underpad, and Povidone-Iodine swabs. Used in hospitals, nursing homes, rehabilitation facilities, or home environments by patients or caregivers. Principle of operation involves manual insertion of the catheter through the urethra into the bladder to facilitate urine drainage into the collection bag. Kit design aims to provide a touchless, hygienic method for bladder management in patients with urinary retention. No electronic or software components.
Clinical Evidence
No clinical data. Substantial equivalence supported by non-clinical functional performance testing, including biocompatibility (ISO 10993 series), sterile catheter performance (ISO 20696, ASTM F623-19, ASTM D8389-2021), urine collection bag testing (ISO 8669-2), and packaging integrity/accelerated aging (ASTM F1980, ASTM F88, ASTM F2096, ISO 11607-1, ASTM D4169).
Technological Characteristics
Single-lumen natural rubber latex catheter with straight tip and lateral drainage eyelets. Pre-lubricated with water-soluble lubricant. Includes 1100cc collection bag. Sterilized via Ethylene Oxide. Dimensions: 12 Fr & 14 Fr, 401 mm length. Complies with ISO 20696, ASTM F623-19, ASTM D8389-2021, and ISO 8669-2.
Indications for Use
Indicated for intermittent urethral catheterization to drain bladder in adult patients (unisex) incapable of voluntary urination.
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
- Bard Touchless II Intermittent Catheter tray (K910653)
Reference Devices
- Self-Cath Closed System (K223821)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
May 29, 2026
C.R. Bard, Inc.
Marc Persad
Senior Regulatory Affairs Specialist
8195 Industrial Blvd.
Covington, Georgia 30014
Re: K254076
Trade/Device Name: BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit
Regulation Number: 21 CFR 876.5130
Regulation Name: Urological catheter and accessories
Regulatory Class: II
Product Code: FCM
Dated: April 29, 2026
Received: April 29, 2026
Dear Marc Persad:
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K254076 - Marc Persad
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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.
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
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(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).
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
# Indications for Use
Submission Number (if known)
K254076
Device Name
BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit
Indications for Use (Describe)
The BD Touchless™ Plus Unisex Urethral Catheter Kit is indicated for intermittent catheterization of the urethra to drain urine from the bladder by adult patients who are not capable of voluntary urination.
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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K254076
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C. R. Bard, Inc.
8195 Industrial Boulevard
Covington, Georgia 30014 USA
bd.com
# 510(k) Summary K254076
In accordance with 21 CFR 807.92, the following information is provided for the BD Unisex Pre-Lubricated Urethral Catheter Kit 510(k) Premarket Notification. This submission was prepared in accordance with 21 CF 807 Subpart E and the FDA's electronic submission template eSTAR.
# 510(k) Owner/Submitter Information
C. R. Bard, Inc.
8195 Industrial Boulevard
Covington, GA 30014
Phone: 770-826-3867
Contact Person: Marc Persad, Senior Regulatory Affairs Specialist
Date of Submission: May 29, 2026
Subject Device
| Trade Name: | BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit |
| --- | --- |
| Common Name(s): | Unisex Pre-Lubricated Urethral Catheter Kit, Rubber Urethral Catheter |
| Recommended Classification Regulation: | 21 CFR 876.5130 |
| Classification: | II |
| Product Code: | FCM |
| Device Classification Name: | Tray, catheterization, sterile urethral, with or without catheter (kit) |
| Review Panel: | Gastroenterology/Urology |
| Basis for Submission: | Modified Device |
Predicate Device
| Trade Name: | Bard Touchless II Intermittent Catheter tray |
| --- | --- |
| Predicate 510(k) Number: | K910653 |
| Common Name(s): | Rubber Utility Catheter, Urological Catheter, All-Purpose Urological Catheter, Latex Intermittent Catheter |
| Recommended Classification Regulation: | 21 CFR 876.5130 |
| Classification: | II |
| Product Code: | FCM |
CONFIDENTIAL
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K254076
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C. R. Bard, Inc.
8195 Industrial Boulevard
Covington, Georgia 30014 USA
bd.com
| Device Classification Name: | Tray, catheterization, sterile urethral, with or without catheter (kit) |
| --- | --- |
| Review Panel: | Gastroenterology/Urology |
The predicate device has not been subjected to any design-related recalls.
Additionally, a reference device was selected within the 510(k) to support updated performance standards.
## Reference Device
| Trade Name: | Self-Cath Closed System |
| --- | --- |
| Reference 510(k) Number: | K223821 |
| Common Name(s): | Intermittent Catheter, Urethral |
| Recommended Classification Regulation: | 21 CFR 876.5130 |
| Classification: | II |
| Product Code: | FCM |
| Device Classification Name: | Tray, catheterization, sterile urethral, with or without catheter (kit) |
| Review Panel: | Gastroenterology/Urology |
## Device Description
The BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit contains a pre-lubricated Red Rubber intermittent urethral catheter that is housed within a urine collection bag. The kit also contains gloves, under pad and Povidone-Iodine swabs. The kit is provided sterile and is intended for single use.
## Indications for Use
The BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit is indicated for intermittent catheterization of the urethra to drain urine from the bladder by adult patients who are not capable of voluntary urination.
CONFIDENTIAL
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K254076
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C. R. Bard, Inc.
8195 Industrial Boulevard
Covington, Georgia 30014 USA
bd.com
# Non-Clinical Data
The following data is provided in support of the substantial equivalence determination and the safety and effectiveness claims of the subject device based on FDA recognized consensus standards and others at the time of submission.
## Biocompatibility:
The biocompatibility evaluation was conducted in accordance with applicable sections of
- ISO 10993-1 – 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 10993-6 – Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
- ISO 10993-10 – Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO 10993-11 – Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- ISO 10993-12 – Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
- ISO 10993-23 – Biological evaluation of medical devices - Part 23: Tests for irritation
## Non-Clinical Functional Performance Testing:
Non-clinical performance testing of the subject device was performed in accordance with applicable sections of
- ISO 20696 – Sterile urethral catheters for single use
- ASTM F623-19 (2025) – Standard Performance Specification for Foley Catheter
- ASTM D8389-2021 – Standard performance specification for urinary intermittent catheters
Non-clinical functional performance testing of the urine collection bag used with the subject device was performed in accordance with applicable sections of
- ISO 8669-2:1996 – Urine collection bags Part 2: Requirements and test methods
Non-clinical performance testing of the subject device’s primary packaging was performed in accordance with applicable sections of
- ASTM F2096 -11(2019) – Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
To demonstrate device and packaging functionality over time, accelerated aging was performed to simulate aging in accordance with
- ASTM F1980 -2021 – Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM F88/F88M-2023 – Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F2096 -11(2019) – Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
CONFIDENTIAL
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KD
K254076
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C. R. Bard, Inc.
8195 Industrial Boulevard
Covington, Georgia 30014 USA
bd.com
- ISO 11607-1 2019-02 – Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ASTM D4169-2023 – Standard Practice for Performance Testing of Shipping Containers and Systems
All tests met the requirements of the pre-determined acceptance criteria.
## Technological Characteristic Comparison
The subject BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit has similar technological characteristics compared to the predicate device, Bard Touchless II Intermittent Catheter tray, cleared via K910653. The subject and predicate devices share the following elements:
- Same intended use
- Same principle of operation
- Same design features and technological characteristics
- Provided sterile for single-use
Table 1 below provides a comparison of the technological characteristics between the subject and predicate devices. The subject device is substantially equivalent to the predicate device since they share the same technological characteristics as noted above. The subject device when compared to the predicate device differs in the indications for use statement and the supplier of the latex material. The minor difference in technological characteristics does not raise different questions of safety and effectiveness..
## Conclusion
The subject BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit has the same intended use and similar technological characteristics as the predicate device. The subject device is substantially equivalent to the legally marketed predicate device as demonstrated by the substantial equivalence comparisons and performance data, and the subject device does not raise different questions of safety and effectiveness for its intended use.
CONFIDENTIAL
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K254076
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C. R. Bard, Inc.
8195 Industrial Boulevard
Covington, Georgia 30014 USA
bd.com
Table 1. Technological Characteristic Comparison
| Design/Technological Characteristic | Subject Device K254076 BD Touchless® Plus Unisex Pre-Lubricated Urethral Catheter Kit | Predicate Device K910653 Bard Touchless II Intermittent Catheter Tray |
| --- | --- | --- |
| Regulation Number | 21 CFR 876.5130 | 21 CFR 876.5130 |
| Regulation Description | Urological Catheter and Accessories | Urological Catheter and Accessories |
| Product Code | FCM | FCM |
| Classification | II | II |
| Intended Use | Intermittent catheterization of the urethra to drain urine from the bladder | Intermittent catheterization of the urethra to drain urine from the bladder |
| Indications for Use | The BD Touchless™ Plus Unisex Urethermal Catheter Kit is indicated for intermittent catheterization of the urethra to drain urine from the bladder by adult patients who are not capable of voluntary urination. | For Urological Use Only. |
| Target Population | Adult patients, Unisex | Adult patients, Unisex |
| Sterile State | Provided sterile | Provided sterile |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide |
| Condition of Use | Single Use | Single Use |
| Principle of Operation | Device is passed to the urinary bladder via the urethra. | Device is passed to the urinary bladder via the urethra. |
| Catheter Design | Single lumen catheter with lateral opposing drainage eyelets (proximal end, inserted into body orifice) to funnel (distal end) | Single lumen catheter with lateral opposing drainage eyelets (proximal end, inserted into body orifice) to funnel (distal end) |
| Where Used | Hospital, nursing home, rehabilitation facilities, or home use environment | Hospital, nursing home, rehabilitation facilities, or home use environment |
| Catheter Material | Natural Rubber Latex | Natural Rubber Latex |
| Catheter Coating | Pre-Lubricated, Water-soluble lube | Pre-Lubricated, Water-soluble lube |
| Tip Configuration | Straight tip | Straight tip |
| Diameter/French Sizes | 12 Fr & 14 Fr | 12 Fr & 14 Fr |
| Effective Length | 401 mm | 401 mm |
| Urine collection bag, size | Self-contained, 1100cc | Self-contained, 1100cc |
| Kit Accessories | Povidione Iodine Swabs 2 Ambidextrous gloves Waterproof underpad | Povidione Iodine Swabs 2 Ambidextrous gloves Waterproof underpad |
CONFIDENTIAL
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