0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe

K250884 · Becton, Dickinson and Company · NGT · Dec 2, 2025 · General Hospital

Device Facts

• Record ID: K250884
• Device Name: 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe
• Applicant: Becton, Dickinson and Company
• Product Code: NGT · General Hospital
• Decision Date: Dec 2, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe is intended to be used only for the flushing of indwelling vascular access devices.

Device Story

BD PosiFlush™ SP Syringe is a sterile, single-use, three-piece syringe pre-filled with 0.9% Sodium Chloride Injection, USP. It features a Luer connector compatible with ISO 80369-7 standards and is sealed with a tip cap. The device is used in clinical settings by healthcare professionals to flush indwelling vascular access devices, preventing occlusion and maintaining patency. The syringe is manually operated; the user removes the tip cap, connects the syringe to the vascular access device, and depresses the plunger to deliver the saline. This process clears the catheter of blood or medication residues, reducing the risk of complications and improving patient outcomes by ensuring continued access for therapy.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including performance/design verification (e.g., tip cap torque, reflux, leakage, break loose/breakout/sustaining forces, expelled volume), chemical analysis (NaCl assay, pH, iron, heavy metals), and biocompatibility testing (cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, hemocompatibility).

Technological Characteristics

Three-piece syringe with Luer connector (ISO 80369-7). Materials: Polypropylene barrel/plunger rod, Styrene-Butadiene Rubber stopper, silicone lubricant. Sterilization: Moist heat (SAL 10^-6). Dimensions: 10 mL configuration. No electronic components or software.

Indications for Use

Indicated for flushing indwelling vascular access devices in patients requiring maintenance of catheter patency.

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 PosiFlush™ SP Syringe (K161552)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

December 2, 2025

Becton, Dickinson and Company
Anamika Tiwari
Staff Regulatory Affairs Specialist
1 Becton Drive
Franklin Lakes, New Jersey 07417

Re: K250884
Trade/Device Name: 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe
Regulation Number: 21 CFR 880.5200
Regulation Name: Intravascular Catheter
Regulatory Class: Class II
Product Code: NGT
Dated: November 4, 2025
Received: November 5, 2025

Dear Anamika Tiwari:

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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K250884 - Anamika Tiwari
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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 ([e-mail]) or phone [phone] or 301-796-7100).

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K250884 - Anamika Tiwari
Page 3

Sincerely,

ALLAN GUAN -S

For Bifeng Qian, M.D., Ph.D.
Assistant Director
DHT4C: Division of Infection
Control Devices
OHT4: Office of Surgical and
Infection Control 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 [phone]
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) K250884 | |
| Device Name 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe | |
| Indications for Use (Describe) The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe is intended to be used only for the flushing of indwelling vascular access devices. | |
| 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 [e-mail] | |
| "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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BD

# 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Saline Flush Syringe 510(k) Summary (21 CFR §807.92)

K250884

| Submitter Information | Submitter Name:
Submitter Address:
Contact Person:
Email Address:
Phone Number:
Fax Number:
Date of Preparation: | Becton, Dickinson, and Company
1 Becton Drive, Franklin Lakes, NJ 07417
Anamika Awadhesh Tiwari
Staff Regulatory Affairs Specialist
[e-mail]
201.847.5005
201.847.5307
December 1st, 2025 |
| --- | --- | --- |
| Subject Device | Trade Name:
Model Number:
Common Name:
Regulation Number:
Classification Name:
Regulatory Class:
Product Code:
Classification Panel: | 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe
306546
0.9% Sodium Chloride Injection Flush Syringe
21 CFR 880.5200
Saline, Vascular Access Flush
Class II
NGT
General Hospital |
| Predicate Device | 510(k) Number:
Trade Name:
Common Name:
Regulation Number:
Classification Name:
Regulatory Class:
Product Code:
Classification Panel: | K161552
0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe
0.9% Sodium Chloride Injection Flush Syringe
21 CFR 880.5200
Saline, Vascular Access Flush
Class II
NGT
General Hospital |

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| Device Description | BD PosiFlush™ SP Syringe is a three-piece, single use syringe with a Luer connector that is compatible with ISO 80369-7:2021 small-bore connectors for liquids and gases in healthcare applications- Part 7: Connectors for intravascular or hypodermic applications. The syringe is prefilled with 0.9% sodium chloride injection, USP and sealed with a tip cap. PosiFlush™ SP Syringe is individually packaged inside a flow wrap. The moist heat sterilization process renders the syringe a Sterility Assurance Level of 10^{-6} for the fluid path and saline solution. |
| --- | --- |
| Indications for Use | The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe is intended to be used only for the flushing of indwelling vascular access devices. |
| Technological Characteristics | The following table provides a comparison between the subject and predicate devices. |

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| Attribute | Subject Device
(BD PosiFlush™ SP Syringe)
K250884 | Predicate Device
(BD PosiFlush™ SP Syringe (K161552)) | Comparison |
| --- | --- | --- | --- |
| Intended Use/
Indications for Use | The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe is intended to be used only for the flushing of indwelling vascular access devices. | The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe is intended to be used only for the flushing of indwelling vascular access devices. Catalog Number 306547 10 mL BD PosiFlush™ SP Syringes are generally compatible for use with syringe pumps. | Similar
(306547 is not in scope of this 510k) |
| Operating Principle | The BD PosiFlush™ SP Syringe is a three- piece, sterile, single use syringe with a 6% (Luer) connector pre- filled with 0.9% Sodium Chloride Injection, USP, and sealed with a tip cap. | The BD PosiFlush™ SP Syringe is a three-piece, sterile, single use syringe with a 6% (Luer) connector pre- filled with 0.9% Sodium Chloride Injection, USP, and sealed with a tip cap. | Identical |
| Syringe Configuration | 10 mL | 3, 5, and 10mL | Different |
| Single Use? | Yes | Yes | Identical |
| Sterile? | Sterile Fluid Path | Sterile Fluid Path | Identical |
| Use in Sterile Field? | No | No | Identical |
| Content of syringe package | One pre-filled syringe per flow wrap pack | One pre-filled syringe per flow wrap pack | Identical |
| Device Components | • Barrel
• 0.9% NaCl USP solution
• Plunger Rod
• Tip Cap
• Stopper | • Barrel
• 0.9% NaCl USP solution
• Plunger Rod
• Tip Cap
• Stopper | Identical |

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| Barrel Material | Polypropylene | Polypropylene | Similar (Subject device material is assessed as per ISO 10993-1) |
| --- | --- | --- | --- |
| Barrel Lubricant | Silicone | Silicone | Identical |
| Plunger Rod Material | Polypropylene | Polypropylene | Identical |
| Stopper Material | Styrene-Butadiene Rubber | Styrene-Butadiene Rubber | Identical |
| Stopper Lubricant | Silicone | Silicone | Identical |
| Tip Cap Material | Polypropylene | Polypropylene | Similar (Subject device material is assessed as per ISO 10993-1) |
| Tip Cap Colorant | White | White | Identical |
| Packaging Configuration | • Flow Wrap
• Shelf Carton
• Case Carton | • Flow Wrap
• Shelf Carton
• Case Carton | Identical |
| Primary Packaging Material | Flow wrap | Flow wrap | Identical |
| Mode of Sterilization | Moist Heat | Moist Heat | Identical |
| SAL | 10^{-6} | 10^{-6} | Identical |
| Shelf Life | 1 year | 3 years | Different |
| Biocompatibility testing | • Cytotoxicity
• Sensitization
• Intracutaneous Reactivity
• Material-mediated Pyrogenicity
• Acute Systemic Toxicity | • Cytotoxicity
• Hemolysis
• Acute systematic toxicity
• Sub Chronic Toxicity
• Intracutaneous Reactivity
• Ocular Irritation | Different |

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| | • Hemocompatibility | • Partial Thromboplastin Time
• Sensitization
• Pyrogenicity
• Genotoxicity
• Chemical extractable analysis | |
| --- | --- | --- | --- |
| Performance testing | • Tip Cap Removal Torque
• Reflux
• Tip Cap Leakage
• Leakage past Stopper
• Break loose force
• Breakout Force
• Sustaining Force
• Retaining Ring Force
• Expelled Volume
• NaCl Chemistry Testing
• Particulate Analysis
• Appearance and Solution Clarity
• Barrel Transparency
• Distribution Test | • Container Closure Integrity
• Break loose force
• Breakout force
• Sustaining force
• Stopper Separation
• Leakage
• Pump Force
• Distribution Test
• Dead Space
• Syringe Induced Reflux | Different |

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Discussion
The subject device and predicate device are different with respect to the following item:
1. The barrel and tip cap resin of both subject and predicate device is different.
2. The subject device’s configuration includes the 10ml, when compared to the 3ml, 5ml, and 10mL configurations of the predicate device.

The different technological characteristics between the subject and predicate device are evaluated in performance testing, biocompatibility tests, and distribution tests demonstrating that there are no new or different questions of safety and effectiveness.

Non-Clinical Testing
BD has performed the following performance tests in accordance with 21 CFR §820.30 to demonstrate that the PosiFlush™ SP Syringe performs equivalent to the predicate devices.
The following tests were performed on the subject device to an internal specification or a Standard:

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| Test | Purpose | Acceptance Criteria | Result |
| --- | --- | --- | --- |
| Performance/Design Verification Tests | | | |
| Tip Cap Removal Torque | Measure the torque required to remove the tip cap from the syringe | Tip Cap can be twisted off as per BD validated force | Pass |
| Reflux | Measure the potential blood reflux into the catheter from PosiFlush™ SP syringe | Reflux greater than BD validated internal value | Pass |
| Tip Cap Leakage | Evaluate the resistance to leakage between the barrel Luer and the tip cap for pre- filled syringes | No evidence of Tip Cap leakage | Pass |
| Leakage past Stopper | Evaluate the resistance to leakage between the barrel and stopper ribs | No leakage of solution past the stopper ribs | Pass |
| Break loose force | Measure the initial maximum force required to move the plunger rod/stopper in the syringe barrel | Force to move plunger rod/stopper is less than the BD validated force | Pass |
| Breakout Force | Measure the maximum force required to move the plunger rod/stopper in the syringe barrel a short time after initially moving the plunger rod/stopper | | Pass |
| Sustaining Force | Measure the average force required to move the plunger rod/stopper in the syringe barrel | | Pass |
| Retaining Ring Force | Measure the force necessary to remove the plunger rod/stopper assembly from the syringe barrel after assembly | Force to move plunger rod/stopper is greater than the BD validated force | Pass |
| Expelled Volume | Measure the volume of saline solution expelled from the syringe | USP43-NF38 <697>Container Content for Injections | Pass |
| NaCl Assay | Measure the NaCl concentration saline solution in syringe samples | 0.9% NaCl Injection USP Monograph | Pass |
| pH | Measure the pH of saline solution in syringe samples | 0.9% NaCl Injection USP Monograph and USP43-NF38 <791> pH | Pass |

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| Iron | Measure the amount of iron in saline solution | 0.9% NaCl Injection USP Monograph and USP43-NF38 <241> Iron | Pass |
| --- | --- | --- | --- |
| Heavy Metals | Measure the heavy metals such as Cadmium, Arsenic, Cobalt, Vanadium, Copper, Lead, Nickel, Lithium, Antimony and Mercury in saline solution | USP43-NF38 <232> Elemental Impurities - Limits | Pass |
| NaCl Solution weight loss | Measure the weight loss of saline solution in pre-filled saline syringes | USP43-NF38 <671> Containers Performance Testing | Pass |
| UV Analysis | Measure the UV absorbance between 220-360 nm for pre- filled saline syringes | < 0.4 AU | Pass |
| Bacterial Endotoxin | Determine the amount of endotoxin in saline pre-filled syringes | 0.9% NaCl Injection USP Monograph and USP43-NF38 <85> Bacterial Endotoxins Test | Pass |
| Sterility | To verify 10-6SAL in the fluid path. | Sterile; No growth in media | Pass |
| Surface Sterility | To verify 10-6SAL on all surface of syringe and inside surface of primary packaging | | Pass |
| Particulate Analysis | Measure the number of particulates in saline pre-filled syringes | ≥ 10 μm < 3,000 ≥ 25 μm < 300 | Pass |
| Appearance and Solution Clarity/ Barrel Transparency | Examine appearance, solution clarity and barrel transparency in pre-filled saline syringes | Solution and components are clear | Pass |
| Distribution Test | Evaluates the product and packaging integrity after distribution. | No unit packaging open seal (end or fin) cuts, tears or holes greater than BD validated internal value. | Pass |
| | | No fluid between specified stopper ribs | Pass |
| | | Container Closure Integrity maintained | Pass |

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| Biocompatibility | | | |
| --- | --- | --- | --- |
| Cytotoxicity | ISO 10993-5:2009
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Grade ≤ 2 | Pass |
| Sensitization | ISO 10993-10:2021
Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization | Non-Sensitizer | Pass |
| Irritation or Intracutaneous Activity | ISO 10993-23:2021
Biological Evaluation of Medical Devices - Part 23: Tests for Irritation | Final Test Sample Score ≤ 1 | Pass |
| Acute Systemic Toxicity | ISO 10993-11:2017
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity | No significantly greater biological reaction than the control | Pass |
| Material Mediated Pyrogenicity | ISO 10993-11:2017
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
USP43-NF38 <151>Pyrogen Test (USP Rabbit Test) | No temperature rise ≥ 0.5° C | Pass |
| Hemocompat-ability | ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials | ≤ 5% hemolysis | Pass |
| Particulate Analysis | Measure the number of particulates in saline pre-filled syringes | ≥ 10 μm < 3,000
≥ 25 μm < 300 | Pass |

The subject device met all the predetermined acceptance criteria for the above listed performance, packaging and biocompatibility tests.

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| Clinical Testing | Not applicable. |
| --- | --- |
| Conclusion | The conclusion drawn from the nonclinical test demonstrates that the subject device 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe is as safe, as effective, and performs as well as or better than the legally marketed predicate device K161552. |

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