BD Plastipak™ Syringe

K251350 · Becton, Dickinson and Company · FMF · Jul 29, 2025 · General Hospital

Device Facts

• Record ID: K251350
• Device Name: BD Plastipak™ Syringe
• Applicant: Becton, Dickinson and Company
• Product Code: FMF · General Hospital
• Decision Date: Jul 29, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

The BD Plastipak™ Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.

Device Story

The BD Plastipak™ Syringe is a three-piece, single-use, sterile, hypodermic syringe; available in 20 mL and 50 mL sizes with eccentric luer slip tip configurations. The device consists of a lubricated polypropylene barrel with a graduated scale, a lubricated polyisoprene rubber stopper, and a polypropylene plunger rod. Operated manually by healthcare professionals in clinical settings, the plunger rod is pulled to aspirate fluids or depressed to inject/expel fluids. The male 6% (Luer) connector attaches to compatible female Luer connectors. The device is provided sterile via Ethylene Oxide (ETO) gas. It functions as a standard piston syringe for fluid delivery or aspiration, facilitating medication administration or fluid sampling.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included breakout force, sustaining force, leakage past stopper, volumetric accuracy, dead space, luer leakage, stress cracking, and resistance to separation. Biocompatibility testing included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, and hemocompatibility. All tests met predetermined acceptance criteria.

Technological Characteristics

Three-piece piston syringe. Materials: Polypropylene barrel (HPR35CMD), polyisoprene rubber stopper, silicone lubricant. 6% (Luer) male connector. Sizes: 20 mL, 50 mL. Sterilization: ETO (SAL 10^-6). Standards: ISO 7886-1:2017 (performance), ISO 80369-7:2021 (luer fittings), ISO 10993 series (biocompatibility), ASTM F756-17 (hemocompatibility).

Indications for Use

Indicated for health care professionals for general purpose fluid aspiration/injection.

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

• BD Single Use, Hypodermic Syringe (K980987)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 29, 2025

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

Re: K251350
Trade/Device Name: BD Plastipak™ Syringe
Regulation Number: 21 CFR 880.5860
Regulation Name: Piston Syringe
Regulatory Class: Class II
Product Code: FMF
Dated: April 30, 2025
Received: April 30, 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" (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

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K251350 - Anamika Tiwari
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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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K251350 - Anamika Tiwari
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Sincerely,

# Shruti N. Mistry -S

Shruti Mistry
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 [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) K251350 | |
| Device Name BD Plastipak™ Syringe | |
| Indications for Use (Describe) The BD Plastipak™ Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. | |
| 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

# K251350
BD Plastipak™ Syringe
510(k) Summary (21 CFR §807.92)

| 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 Tiwari
Sr. Regulatory Affairs Specialist
[e-mail]
[phone]
(201)-847-5307
30th June 2025 |
| --- | --- | --- |
| Subject Device | Trade Name:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel: | BD Plastipak™ Syringe
Piston Syringe
21 C.F.R. § 880.5860
Syringe, Piston
Class II device
FMF
General Hospital |
| Predicate Device | Trade Name:
510(k) Reference:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel: | BD Single Use, Hypodermic Syringe
K980987
Piston Syringe
21 C.F.R. § 880.5860
Syringe, Piston
Class II
FMF
General Hospital |

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| Device Description | The BD Plastipak™ Syringe is a three-piece, single use, sterile, hypodermic syringe with a 6% (Luer) male connector in 20 mL and 50 mL eccentric luer slip tip configurations. The BD Plastipak™ Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The syringe barrel incorporates a male 6% (Luer) connector which is connectable to a compatible female 6% (Luer) connector. The BD Plastipak™ Syringe is provided sterile by Ethylene Oxide Gas (ETO) sterilization method. |
| --- | --- |
| Indications for Use | The BD Plastipak™ Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. |
| Technological Characteristics | The following table provides a comparison between the subject and predicate devices. |

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| Attributes | | Subject Devices | Predicate Devices | Comparison |
| --- | --- | --- | --- | --- |
| Intended Use/ Indications for Use | | The BD Plastipak™ Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. | The BD Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. | Identical |
| Operating Principle | | Piston Syringe | Piston Syringe | Identical |
| Syringe configuration | | • 20ml
• 50 ml

(Available in Luer-Slip, Eccentric Tip configuration) | • 1ml
• 3 ml
• 5 ml
• 10 ml
• 20 ml
• 30 ml
• 50 ml

(Available in Luer-lok, Luer-Slip, Eccentric Tip configuration) | **Different**

(The syringe sizes covered in the subject submission are within the range of the predicate device sizes) |
| Single Use | | Yes | Yes | Identical |
| Sterile | | Yes | Yes | Identical |
| Use in Sterile field | | Yes | Yes | Identical |
| Device Components | Barrel resin | Polypropylene (HPR35CMD) | Polypropylene (PH-712B) | **Different** |
| | Barrel Lubricant | Silicone Lubricant | Silicone Lubricant | Identical |
| | Barrel Ink | Black Ink | Black Ink | Identical |
| | Plunger Rod | Polypropylene | Polypropylene | Identical |
| | Stopper | Polyisoprene Rubber | Polyisoprene Rubber | Identical |
| | Stopper Lubricant | Silicone Lubricant | Silicone Lubricant | Identical |
| Packaging Configuration | • Blister pack (Primary) | • Blister pack (Primary) | Identical | |
| | | • Shelf Carton (Secondary) | | • Shelf Carton (Secondary) |
| Packaging Material | • Primary- Direct seal paper on Polymer Film | • Primary- Direct seal paper on Polymer Film | Identical | |
| | | • Secondary- Corrugated cardboard | | • Secondary- Corrugated cardboard |

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| Content of syringe package | Sterile: | One syringe per pack (Blister Pack) | One syringe per pack (Blister Pack) | Identical |
| --- | --- | --- | --- | --- |
| Sterilization Method | | ETO | ETO | Identical |
| SAL | | 10^{-6} | 10^{-6} | Identical |
| Shelf Life | | 5 years | 5 years | Identical |

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Discussion
The subject device and predicate device are different with respect to the following item:
1. Change in component material (Barrel resin and supplier)
The purpose of this premarket submission is to introduce new barrel resin material and supplier for the BD Hypodermic Syringe cleared under K980987. Change is being made to allow contingency and reduce supply chain risk of BD Plastipak™ Syringe (subject device). The predicate device covered in Premarket notification K980987 are available in additional volumes i.e., 1ml, 3ml, 5ml, 10ml, 20ml, 30ml and 50ml sizes in Luer- lok, Luer- Slip, & Eccentric tip configuration. The subject device will be available in 20 ml and 50 ml Luer-Slip, Eccentric tip configuration that are covered within the range of the predicate device. Only 20 ml and 50 ml BD Plastipak™ Syringe are affected by the change described in the subject 510(k) Premarket Notification. No change will be made to the product's intended use, technological design, or performance.
The different technological characteristics between the subject and predicate device are evaluated in bench performance testing, and biocompatibility tests demonstrating that there are no new questions or modified risk 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 BD Plastipak™ Syringe performs equivalent to the predicate device.
These tests were performed on the subject device to an internal specification or a Standard:

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| Performance Testing | |
| --- | --- |
| Test | Purpose |
| Breakout Force | ISO 7886-1:2017- Performance evaluation of force to operate the piston. |
| Sustaining Force | ISO 7886-1:2017- Evaluation of force to operate the piston. |
| Leakage Past Stopper | ISO 7886-1:2017- Evaluation of Freedom from air and liquid leakage past plunger stopper. |
| Volumetric Accuracy | ISO 7886-1:2017- Evaluation of Volumetric Accuracy |
| Dead Space | ISO 7886-1:2017- Evaluation of residual volume |
| Luer Leakage | ISO 80369-7:2021 - Evaluation of the luer fittings for leakage |
| Stress Cracking | ISO 80369-7:2021- Evaluation of the luer fittings for stress cracking |
| Resistance to separation from axial load | ISO 80369-7:2021- Evaluation of the luer fitting for separation when subjected to axial force. |
| Biocompatibility | |
| Cytotoxicity | ISO 10993-5:2009- Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
| Sensitization | ISO 10993-10:2021- Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization |
| Intracutaneous Reactivity | ISO 10993-23:2021- Biological evaluation of medical devices- Test for Irritation |
| Acute Systemic Toxicity | ISO 10993-11:2017- Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| 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) |
| Hemocompatibility | 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 |

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

| Clinical Testing | Not applicable. |
| --- | --- |
| Summary of Substantial Equivalence | The differences between predicate and the subject device do not raise any new questions or modified risks of safety or effectiveness when compared. Therefore, BD Plastipak™ Syringe is substantially equivalent to the predicate device cleared under K980987. |