BD Saf-T-Intima™ Subcutaneous Catheter System
Device Facts
| Record ID | K251422 |
|---|---|
| Device Name | BD Saf-T-Intima™ Subcutaneous Catheter System |
| Applicant | Becton Dickinson Infusion Therapy Systems, Inc. |
| Product Code | FOZ · General Hospital |
| Decision Date | Oct 8, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5200 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
BD Saf-T-Intima™ Subcutaneous Catheter System is intended to be inserted into a patient’s subcutaneous tissue for short term use for the administration of fluids and medications. This device is also intended to be inserted into a patient’s peripheral venous system for short term use to administer fluids or sample blood. This device may be used for any patient population with consideration given to adequacy of subcutaneous tissue or vascular anatomy, procedure being performed, fluids being infused, and duration of therapy.
Device Story
Over-the-needle subcutaneous and intravenous catheter; includes radiopaque BD Vialon™ catheter, needle with wire stylet, wings for securement, integrated extension tubing, clamp, single or dual port, PRN adapter, vent plug, and needle shield. Passive needle protection mechanism activates upon removal to prevent needlestick injuries. Used in clinical settings by healthcare providers for short-term fluid/medication delivery or blood sampling. Device maintains blood containment during insertion. Color-coded wings/ports indicate gauge size (22G, 24G). Benefits include reduced needlestick risk and versatile access for subcutaneous or peripheral venous therapy.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including compliance with ISO 80369-7, ISO 10555-1/7, ISO 23908, ISO 11607, ISO 10993-1, and ISO 11135-1. Internal studies verified peak insertion force, catheter drag force, needle removal force, and decouple force. Usability testing conducted per FDA human factors guidance.
Technological Characteristics
Single-lumen winged polyurethane catheter with integrated extension set (single or dual port). Materials: Stainless steel needle/wedge, BD Vialon™ tubing, silicone lubricant, PVC (DOA plasticizer) wings/tubing, ABS clamp, polypropylene Y-adapter/vent plug/shield, polyisoprene stopper, polycarbonate luer lock. Standards: ISO 10993 (biocompatibility), ISO 80369-7 (connectors), ISO 10555 (catheters), ISO 23908 (sharps protection), ISO 11607 (packaging), ISO 11135 (sterilization).
Indications for Use
Indicated for any patient population requiring short-term subcutaneous administration of fluids/medications or peripheral venous access for fluid administration or blood sampling, contingent upon adequate tissue/vascular anatomy and procedure appropriateness.
Regulatory Classification
Identification
An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.
Predicate Devices
- BD Saf-T-Intima™ Intravascular Catheter (K013800)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
October 8, 2025
Becton Dickinson Infusion Therapy Systems Inc.
Sunny Patel
Senior Regulatory Affairs Specialist
9450 South State Street
Sandy, Utah 84070
Re: K251422
Trade/Device Name: BD Saf-T-Intima™ Subcutaneous Catheter System
Regulation Number: 21 CFR 880.5200
Regulation Name: Intravascular Catheter
Regulatory Class: Class II
Product Code: FOZ
Dated: September 5, 2025
Received: September 5, 2025
Dear Sunny Patel:
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"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K251422 - Sunny Patel
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(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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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 systems (QS) regulation (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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K251422 - Sunny Patel
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Sincerely,
David Wolloscheck -S
David Wolloscheck, Ph.D.
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) K251422 | |
| Device Name BD Saf-T-Intima™ Subcutaneous Catheter System | |
| Indications for Use (Describe) BD Saf-T-Intima™ Subcutaneous Catheter System is intended to be inserted into a patient’s subcutaneous tissue for short term use for the administration of fluids and medications. This device is also intended to be inserted into a patient’s peripheral venous system for short term use to administer fluids or sample blood. This device may be used for any patient population with consideration given to adequacy of subcutaneous tissue or vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. | |
| 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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B
BDC
Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com
# K251422 510(k) Summary (21 CFR §807.92)
BD Saf-T-Intima™ Subcutaneous Catheter System
| Submitter Information | Submitter Name: Submitter Address: Contact Person: Email Address: Phone Number: Date of Preparation: | Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street, Sandy, Utah 84070 Sunny Patel, Senior Regulatory Affairs Specialist sunny.patel@bd.com 801-522-5132 October 03, 2025 |
| --- | --- | --- |
| Subject Device | Trade Name: Common Name: Regulation Number: Regulation Name: Regulatory Class: Product Code: Classification Panel: | BD Saf-T-Intima™ Subcutaneous Catheter System Short-term less than 30 days intravascular, therapeutic catheter 21 CFR 880.5200 Intravascular catheter II FOZ General Hospital |
| Predicate Device | Trade Name: 510(k) Reference: Common Name: Regulation Number: Regulation Name: Regulatory Class: Product Code: Classification Panel: | BD Saf-T-Intima™ Intravascular Catheter K013800 Short-term less than 30 days intravascular, therapeutic catheter 21 CFR 880.5200 Intravascular catheter II FOZ General Hospital |
| Device Description | BD Saf-T-Intima™ Subcutaneous Catheter System is an over-the-needle subcutaneous and intravenous (IV) catheter. This device includes a radiopaque BD Vialon™ Catheter Material, a needle attached to a wire stylet, wings for insertion assistance and catheter securement, integrated extension tubing, a clamp, a single or dual port, a BD® PRN Adapter, vent plug (dual port only), and a needle shield. The needle and catheter are protected by a needle cover. BD Saf-T-Intima™ Subcutaneous Catheter System is designed to keep blood contained within the device throughout the insertion process. The needle is passively protected when it is removed, reducing the risk of accidental needlestick injury. Both the wings and single port or dual port are color coded to indicate catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue). | |
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Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com
| Indications for Use
(21 CFR § 807.92(a)(5)) | **BD Saf-T-Intima™ Subcutaneous Catheter System**
BD Saf-T-Intima™ Subcutaneous Catheter System is intended to be inserted into a patient’s subcutaneous tissue for short term use for the administration of fluids and medications. This device is also intended to be inserted into a patient’s peripheral venous system for short term use to administer fluids or sample blood. This device may be used for any patient population with consideration given to adequacy of subcutaneous tissue or vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. |
| --- | --- |
| Technological Characteristics | Technological characteristics of the subject and predicate devices are the same. The subject and predicate devices are a single-lumen winged polyurethane IV or subcutaneous use catheter with an integrated extension set incorporating either a single port (straight connection with PRN adapter) or dual port (Y connection with PRN adapter and vent plug). The subject and predicate devices’ intended use is based on the same technology and principles of operation. Therefore, the subject device is considered substantially equivalent to the predicate device, BD Saf-T-Intima™ Intravascular Catheter, K013800. Any modifications made to the subject device have been determined to have no impact to the safety or performance of the device. Any new or different risks have been documented and reduced as far as practicable following risk management practices outlined in ISO 14971.
A comparison of the subject and predicate device technological characteristics is provided in the table below. |
Page 2 of 8
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Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com
NOTE: Highlighted blue text indicates differences between the subject and predicate device.
Table 1-1. Comparison of Subject / Predicate Device
| Attribute | SUBJECT (K251422)
BD Saf-T-Intima™ Subcutaneous Catheter System | PREDICATE (K013800)
BD Saf-T-Intima™ Intravascular Catheter | Substantially Equivalent? |
| --- | --- | --- | --- |
| Trade Name | BD Saf-T-Intima™ Subcutaneous Catheter System | BD Saf-T-Intima™ Intravascular Catheter | Yes
Minor descriptive changes. |
| Common Name | Peripheral Intravascular Catheter or IV Catheter | Peripheral Intravascular Catheter or IV Catheter | Yes |
| Regulation Number | 21 CFR §880.5200 | 21 CFR §880.5200 | Yes |
| Regulatory Name | Intravascular Catheter | Intravascular Catheter | Yes |
| Regulatory Class | II | II | Yes |
| Product Code | FOZ | FOZ | Yes |
| Classification Panel | General Hospital | General Hospital | Yes |
| Intended Use | BD Saf-T-Intima™ Subcutaneous Catheter System is intended for short term use to sample blood and administer fluids. | BD Saf-T-Intima™ Safety System is intended for short term use to sample blood and administer fluids. | Yes
Minor descriptive changes. |
| Indications for Use | Single Port / Dual Port:
BD Saf-T-Intima™ Subcutaneous Catheter System is intended to be inserted into a patient’s subcutaneous tissue for short term use for the administration of fluids and medications. This device is also intended to be inserted into a patient’s peripheral venous system for short term use to administer fluids or sample blood. This device may be used for any patient population with consideration given to adequacy of subcutaneous tissue or | An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient’s vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. | Yes
The Indications for Use for the BD Saf-T-Intima™ Subcutaneous Catheter System is being narrowed to sample blood or administer fluids (Intravenous use ONLY). The indications for use are also expanded to include anatomical site-specific use for subcutaneous access.
These modifications are intended to provide clarity for device use |
Page 3 of 8
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Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com
| Attribute | SUBJECT
BD Saf-T-Intima™ Subcutaneous Catheter System | PREDICATE (K013800)
BD Saf-T-Intima™ Intravascular Catheter | Substantially Equivalent? |
| --- | --- | --- | --- |
| | vascular anatomy, **procedure being performed**, **fluids being infused**, and **duration of therapy**. | | with no change to patient population or use duration. The proposed Indications for Use fall within the general intended use and does not raise any new or different questions of safety or effectiveness, nor impact the performance of the device |
| Fundamental Scientific Technology | A single-winged, polyurethane IV catheter with an integrated extension set incorporating either a single port or Y (dual)-port injection site. | A single-winged, polyurethane IV catheter with an integrated extension set incorporating either a single port or Y (dual)-port injection site. | Yes |
| ISO 10993 Biocompatibility Contact Type and Duration | *Body contact*: Externally communicating device
*Contact*: Circulating blood
*Contact duration*: Limited (A) to Prolonged (B) (≤ 24 hrs to 30 days | *Body contact*: Externally communicating device
*Contact*: Circulating blood
*Contact duration*: Limited (A) to Prolonged (B) (≤ 24 hrs to 30 days | Yes |
| Catheter Dimensions | *Catheter Diameters*
22 GA, 24 GA
*Catheter Lengths*
0.75 IN | *Catheter Diameters*
18 GA, 20 GA, 22 GA, 24 GA
*Catheter Lengths*
0.75 IN, 1.00 IN | Yes |
| Product Configurations | • Single Port (Straight connection with PRN adapter)
• Dual Port (Y connection with PRN adapter and vent plug) | • Straight connection with PRN adapter
• Y connection (dual port) with PRN adapter and vent plug | Yes |
Page 4 of 8
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Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com
The BD Saf-T-Intima™ Subcutaneous Catheter System is considered substantially equivalent to the predicate device, BD Saf-T-Intima™ Intravascular Catheter (K013800), based on a comprehensive comparison of key attributes. The differences in substantial equivalence between the BD Saf-T-Intima™ Subcutaneous Catheter System and the predicate BD Saf-T-Intima™ Intravascular Catheter primarily involve the indications for use. The subject device expands its indications to include subcutaneous access and narrows its intravenous use to administer fluids or sample blood only, whereas the predicate device includes blood pressure monitoring. Additionally, the subject device offers fewer catheter sizes—only 22 GA and 24 GA with a 0.75-inch length, compared to the predicate's range of 18GA, 20GA, 22GA, 24GA and lengths of 0.75 and 1.00 inches. These differences do not raise new questions of safety or effectiveness and are well supported by data demonstrating substantial equivalence.
Page 5 of 8
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Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com
NOTE: Highlighted blue text indicates differences between the subject and predicate device.
Table 1-2. Comparison of Subject / Predicate Device Material
| Attribute | Component | SUBJECT
BD Saf-T-Intima™
Subcutaneous Catheter System | PREDICATE (K013800)
BD Saf-T-Intima™
Intravascular Catheter | Substantially Equivalent? |
| --- | --- | --- | --- | --- |
| Materials | Needle Cover | Tenite Propionate | Tenite Propionate | Yes |
| | Needle | Stainless Steel | Stainless Steel | Yes |
| | Catheter Tubing | Polyurethane (BD Vialon™) | Polyurethane (BD Vialon™) | Yes |
| | Lubricants | Silicone | Silicone | Yes |
| | Wedge | Stainless Steel | Stainless Steel | Yes |
| | Wings (Wing Inserter) | PVC with DOA (non-DEHP)
plasticizer | PVC with DEHP plasticizer | Yes;
The modified plasticizer meets the existing performance acceptance criteria including force to Detach Extension Tube from Winged Inserter and Luer Adapter. BD assessed the physical properties and determined modified plasticizer resulted in the same hardness, elongation, and modulus. BD determined there is no change to performance or safety to impact the fit, form or function of the device. Biocompatibility end points were evaluated with no unacceptable risks. This change does not change the intended use or raise new or different questions of safety or effectiveness. |
Page 6 of 8
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Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com
| Attribute | Component | SUBJECT
BD Saf-T-Intima™
Subcutaneous Catheter System | PREDICATE (K013800)
BD Saf-T-Intima™
Intravascular Catheter | Substantially Equivalent? |
| --- | --- | --- | --- | --- |
| | Extension Tubing | PVC with DOA (non-DEHP)
plasticizer | PVC with DEHP plasticizer | Yes;
The modified plasticizer meets the existing performance acceptance criteria including force to Detach Extension Tube from Winged Inserter and Luer Adapter. BD assessed the physical properties and determined modified plasticizer resulted in the same hardness, elongation, and modulus. BD determined there is no change to performance or safety to impact the fit, form or function of the device.
Biocompatibility end points were evaluated with no unacceptable risks
This change does not change the intended use or raise new or different questions of safety or effectiveness. |
| | Clamp | ABS | ABS | Yes |
| | Adapter Wedge | Stainless Steel | Stainless Steel | Yes |
| | Y Adapter | Polypropylene | Polypropylene | Yes |
| | Vent Plug | Polypropylene & Filter | Polypropylene & Filter | Yes |
| | PRN Adapter Stopper | Polyisoprene | Polyisoprene | Yes |
| | PRN Adapter Shrink Band | PVC | PVC | Yes |
| | PRN AdapterLuer Lock | Polycarbonate | Polycarbonate | Yes |
| | Shield | Polypropylene | Polypropylene | Yes |
| | Stylet Wire | Stainless Steel | Stainless Steel | Yes |
| | Stylet Puller | Polypropylene | Polypropylene | Yes |
| | Glue | Epoxy Resin | Epoxy Resin | Yes |
Page 7 of 8
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Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com
| Summary of Performance Tests | The following performance tests were completed on the subject device and additional limited tests completed to support the determination of substantial equivalence to the predicate device. A risk analysis pe ISO 14971 was conducted to assess the impact of the proposed modifications to the predicate device. BD has determined the technological characteristics between the subject and predicate devices were found to be substantially equivalent. The results of performance testing current and new were found to be applicable to the subject device. The performance tests listed below are to ensure that the subject device meets predetermined design requirements:
1. Compliance Testing
• ISO 80369-7
• ISO 10555-1 / ISO 10555-7
• ISO 23908
• ISO 11607
• ISO 10993-1
• ISO 11135-1
2. BD Internal Studies
• Peak Insertion Force
• Catheter Drag Force
• Style / Needle Removal Force
• Decouple Force (Safety Shield)
3. Usability testing per Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff, issued February 2016
Per design control requirements specified in 21 CFR 820.30, the subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices.
Clinical studies are not required to demonstrate substantial equivalence to the predicate device. |
| --- | --- |
| Summary of Substantial Equivalence | Based on the intended use, technological characteristics, and results of performance testing, the subject BD Saf-T-Intima™ Subcutaneous Catheter System has been demonstrated to be substantially equivalent to the predicate device. |
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