Medline Bag Decanter

K250345 · Medline Industries, LP · LHI · Oct 24, 2025 · General Hospital

Device Facts

• Record ID: K250345
• Device Name: Medline Bag Decanter
• Applicant: Medline Industries, LP
• Product Code: LHI · General Hospital
• Decision Date: Oct 24, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

Intended for the aseptic dispensing of solutions from IV containers. For use in transferring IV fluids/medication from a bag to an IV fluid administration device.

Device Story

Medline Bag Decanter is a single-use, sterile, disposable device for aseptic transfer of IV fluids/medication from source bags to administration sets. Device consists of an injection-molded hollow tube with a spiked end and integrated splash guard; protected by flexible caps. Operated manually by clinicians in clinical settings. Spike accesses source container; fluid flows through tube to administration device. Facilitates safe, aseptic fluid transfer; reduces risk of contamination during medication preparation or fluid administration.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993-1), device appearance, flow rate, leakage, spike penetration force, aseptic presentation, chemical/particulate testing (ISO 8536-4), and packaging validation (ASTM F1886, F1929, F2096, F88).

Technological Characteristics

Materials: ABS (body), PE (caps). Design: Injection-molded hollow tube, spiked end, splash guard, 9-inch length. Energy: None (manual). Connectivity: None. Sterilization: Sterile. Standards: ISO 8536-4 (flow, leakage, chemical, particulate), ISO 8536-2 (spike force), ISO 11607-1 (aseptic presentation), ASTM F1886/F1929/F2096/F88 (packaging).

Indications for Use

Indicated for aseptic dispensing of solutions from IV containers and transferring IV fluids/medication from a bag to an IV fluid administration device. No specific patient population, age, or gender restrictions are defined.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• GCMEDICA Bag Transfer Device (K182819)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

October 24, 2025

Medline Industries, LP.
Susan Carlson
Senior Regulatory Affairs Specialist
Three Lakes Drive
Northfield, Illinois 60093

Re: K250345
Trade/Device Name: Medline Bag Decanter
Regulation Number: 21 CFR 880.5440
Regulation Name: Intravascular administration set
Regulatory Class: Class II
Product Code: LHI
Dated: September 26, 2025
Received: September 26, 2025

Dear Susan Carlson:

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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K250345 - Susan Carlson
Page 2

(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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K250345 - Susan Carlson
Page 3

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 [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) K250345 | |
| Device Name Medline Bag Decanter | |
| Indications for Use (Describe) Intended for the aseptic dispensing of solutions from IV containers. For use in transferring IV fluids/medication from a bag to an IV fluid administration device. | |
| 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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MEDLINE

Medline Industries, LP

Three Lakes Drive

Northfield, IL 60093

510(k) Premarket Notification

Medline Bag Decanter

K250345 510(k) Summary

# 510(k) SUMMARY

[AS REQUIRED BY 21CFR807.92(c)]

## Submitter / 510(k) Sponsor

Applicant Name: Medline Industries, LP

Applicant Address: Three Lakes Drive

Northfield, IL 60093

Registration Number: 1417592

## Submission Correspondent

Contact Name: Susan Carlson

Senior Regulatory Affairs Specialist

Contact Email: [e-mail]

Contact Phone: [phone]

## Summary Preparation Date

October 23, 2025

## Type of 510(k) Submission

Traditional

## Device Name / Classification

Trade Name: Medline Bag Decanter

Common Name: Decanting Device

Classification Name: Set, I.V. Fluid Transfer

Product Code: LHI

Classification Panel: General Hospital & Personal Use

Regulatory Class: Class II

Regulation Number: 21 CFR 880.5440

## Predicate Device

Submission Number: K182819

Trade Name: GCMEDICA Bag Transfer Device

## Device Description

The Medline Bag Decanter is a non-pyrogenic, single use, disposable device, which is supplied sterile. The device comprises of a one-piece transfer device with protective flexible caps at either end. The device is an injection molded hollow tube with a spiked end used to access the source container and withdraw fluid. The spike component is designed with a built-in splash guard. The device is designed for use in transferring IV fluids/medication from a bag to an IV fluid administration device.

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MEDLINE

Medline Industries, LP

Three Lakes Drive

Northfield, IL 60093

510(k) Premarket Notification

Medline Bag Decanter

K250345 510(k) Summary

# Indications for Use

Intended for the aseptic dispensing of solutions from IV containers. For use in transferring IV fluids/medication from a bag to an IV fluid administration device.

# Summary of Technological Characteristics

The proposed device, Medline Bag Decanter (K250345), and the predicate device, GCMEDICA Bag Transfer Device (K182819), are substantially equivalent, as evaluated in the table below.

TABLE 1: COMPARISON OF PROPOSED DEVICE AND PREDICATE DEVICE.

| Device Characteristic | Proposed Device | Predicate Device | Comparison Analysis |
| --- | --- | --- | --- |
| Product Name | Medline Bag Decanter | GCMEDICA Bag Transfer Device | N/A |
| 510(k) Reference | K250345 | K182819 | N/A |
| Product Owner | Medline Industries, LP. | GCMedica Enterprise, LTD. (WUXI) | N/A |
| Product Code | LHI | LHI | Same |
| Regulation Number | 880.5440 | 880.5440 | Same |
| Classification Name | Set, I.V. Fluid Transfer | Set, I.V. Fluid Transfer | Same |
| Classification Panel | General Hospital & Personal Use | General Hospital & Personal Use | Same |
| Intended Use / Indications for Use | Intended for the aseptic dispensing of solutions from IV containers. For use in transferring IV fluids/medication from a bag to an IV fluid administration device. | Intended for the aseptic dispensing of solutions from IV containers. For use in transferring IV fluids/medication from a bag to an IV fluid administration device. | Same |
| Design Features | Proposed Device Model consists of an injection molded hollow tube/spout, spiked end, protective caps, and built-in splash guard. | Predicate Device Model consists of spike, protective caps, hollow tubing/spout, and a splash guard. | Same |
| Design Configurations | Length: 9-inch | Length: 9-inch | Same |
| Materials | Body: ABS
Caps: PE | Body: ABS
Caps: PE | Same |
| Prescription vs. OTC | Prescription Use | Prescription Use | Same |

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MEDLINE

Medline Industries, LP
Three Lakes Drive
Northfield, IL 60093

510(k) Premarket Notification
Medline Bag Decanter
K250345 510(k) Summary

| Device Characteristic | Proposed Device | Predicate Device | Comparison Analysis |
| --- | --- | --- | --- |
| Contact Durations | Externally communicating device intended for indirect blood path contact for a limited contact duration (< 24 hours) | Externally communicating device intended for indirect blood path contact for a limited contact duration (< 24 hours) | Same |
| Sterile vs. Non-Sterile | Sterile | Sterile | Same |
| Disposable vs. Non-Disposable | Disposable | Disposable | Same |
| Single Use vs. Reusable | Single Use | Single Use | Same |

As evidenced by the comparison table above, the proposed device, Medline Bag Decanter (K250345), and the predicate device, GCMEDICA Bag Transfer Device (K182819), have the same characteristics, including intended use, technological characteristics, principles of operation, and design features.

## Summary of Non-Clinical Testing

Testing was conducted to demonstrate substantial equivalence between the proposed device, Medline Bag Decanter (K250345) and the predicate device, GCMEDICA Bag Transfer Device (K182819).

## Biocompatibility Testing

The biological evaluation for the proposed device, Medline Bag Decanter (K250345), was conducted in accordance with FDA guidance document, “Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing” and ISO 10993-1:2018, Biological Evaluation of the Medical Devices – Part 1: Evaluation of Testing within a Risk Management Process.

In accordance with ISO 10993-1, the materials of the Medline Bag Decanter are characterized as an externally communicating device intended for indirect blood path contact for a limited duration (&lt; 24 hours), as such the following biological endpoints were evaluated in the biological evaluation report:

- Physical and Chemical Information
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- Hemocompatibility

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MEDLINE

Medline Industries, LP
Three Lakes Drive
Northfield, IL 60093

510(k) Premarket Notification
Medline Bag Decanter
K250345 510(k) Summary

# Performance Testing (Bench)

The following functional performance tests were conducted on the proposed device, Medline Bag Decanter (K250345) to ensure that the device meets the standard specifications for fluid decanters in accordance with applicable requirements outlined in FDA guidance document entitled "Guidance for Industry and FDA Review Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]" and to demonstrate the safety and effectiveness the device for its intended use.

- Device Appearance/Visual Inspection
- Device Flow Rate per ISO 8536-4:2019
- Device Leakage per ISO 8536-4:2019
- Device Spike Penetration Force per ISO 8536-2:2023
- Aseptic Presentation Testing per ISO 11607-1:2019 [Including AMD1:2023]
- Chemical Testing per ISO 8536-4:2019
- Particulate Testing per ISO 8536-4:2019
- Simulated Use Testing/Design Validation
- Packaging Appearance/Visual Inspection per ASTM F1886/F1886M-16
- Packaging Blue Dye Penetration per ASTM F1929-15
- Packaging Bubble Leak Test per ASTM F2096-11 (Reapproved 2019)
- Packaging Seal Strength per ASTM F88/F88M-21

# Performance Testing (Animal)

This section does not apply. No animal testing was performed.

# Performance Testing (Clinical)

This section does not apply. No clinical testing was performed.

# Conclusion

Based on the information provided in this premarket notification and in accordance with 21 CFR Part 807, Medline Industries, LP. concludes that the proposed device, Medline Bag Decanter (K250345), is substantially equivalent to the predicate device, GCMEDICA Bag Transfer Device (K182819), with respect to safety and effectiveness of the device in accordance with its intended use.