SMARTeZ™ Elastomeric Infusion Pump (RS series)
Device Facts
| Record ID | K250234 |
|---|---|
| Device Name | SMARTeZ™ Elastomeric Infusion Pump (RS series) |
| Applicant | Epic Medical Pte. , Ltd. |
| Product Code | MEB · General Hospital |
| Decision Date | Apr 24, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The SMARTeZ Pump (Long infusion time article) is intended for continuous infusion of medications for general infusion use, including pain management. • Routes of administration: intravenous and subcutaneous. The SMARTeZ Pump (Short infusion time article) is intended for continuous infusion of medications for general infusion use, including antibiotic delivery. • Route of administration: intravenous. The SMARTeZ Pump (Chemotherapy article) is intended for continuous infusion of chemotherapy medications. • Routes of administration: intravenous and intra-arterial.
Device Story
SMARTeZ™ RS is a sterile, single-use, non-electronic elastomeric infusion pump for continuous drug delivery. Device utilizes a self-pressuring elastomeric silicone rubber reservoir as energy source; fluid is driven through an integrated administration line and flow restrictor to patient. Flow control relies on Hagen-Poiseuille law via tubing inner diameter restriction. Subject device features a hard outer shell and an inline valve fill port with TPU tubing, differing from the predicate's soft shell. Operated by healthcare professionals in clinical settings; device is not for fluid storage. Output is continuous fixed-rate medication delivery. Benefits include reliable, portable, non-electric infusion therapy for various parenteral drugs.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench performance testing, including leak-proof tests, flow rate accuracy tests (nominal, accelerated aging, pressure, and temperature conditions), Luer lock connection testing, and biocompatibility assessments (ISO 10993-1, -4, -5, -10, -11, -18, -23).
Technological Characteristics
Non-electronic elastomeric pump. Materials: silicone rubber reservoir, plastic/TPU tubing, plastic flow restrictor. Energy: elastic recoil of reservoir membrane. Flow control: Hagen-Poiseuille law via micro-bore/capillary restrictor. Connectivity: None. Sterilization: Ethylene Oxide (SAL 10⁻⁶). Standards: ISO 28620:2020, ISO 80369-7:2021, ISO 10993 series.
Indications for Use
Indicated for patients requiring continuous infusion of parenteral medications, including pain management, antibiotics, and chemotherapy. Routes include intravenous, subcutaneous, and intra-arterial administration. Intended for use by trained healthcare professionals in clinical settings.
Regulatory Classification
Identification
An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
Predicate Devices
- SMARTeZ™ Elastomeric Infusion Pump (K151650)
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
April 24, 2026
Epic Medical Pte. Ltd.
Freddie Lee
Chief Executive Officer/Managing Director
105 Cecil Street #20-04
The Octagon
Singapore 069534
Re: K250234
Trade/Device Name: SMARTeZ™ Elastomeric Infusion Pump (RS series)
Regulation Number: 21 CFR 880.5725
Regulation Name: Infusion Pump
Regulatory Class: Class II
Product Code: MEB
Dated: March 25, 2026
Received: March 25, 2026
Dear Freddie Lee:
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.
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K250234 - Freddie Lee
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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 (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
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K250234 - Freddie Lee
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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,
Jake K. Lindstrom -S
Jake Lindstrom, 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)
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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) K250234 | |
| Device Name SMARTeZ™ Elastomeric Infusion Pump (RS series) | |
| Indications for Use (Describe) The SMARTeZ Pump (Long infusion time article) is intended for continuous infusion of medications for general infusion use, including pain management. • Routes of administration: intravenous and subcutaneous. The SMARTeZ Pump (Short infusion time article) is intended for continuous infusion of medications for general infusion use, including antibiotic delivery. • Route of administration: intravenous. The SMARTeZ Pump (Chemotherapy article) is intended for continuous infusion of chemotherapy medications. • Routes of administration: intravenous and intra-arterial. | |
| 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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EPIC
# K250234 – 510(k) Summary
## I. Submitter
Epic Medical Pte. Ltd.
105 Cecil Street #20-04
The Octagon
Singapore 069534
Phone: +65 9635 2618 / +66 81 761 5292
Contact Person: Mr. Freddie LEE, Chief Executive Officer/ Managing Director
Date Prepared: April 15, 2026
Content and Format: Prepared in accordance with 21 CFR 807.92
Type of Submission: Traditional
## II. Subject Device
| 510(k) Number: | K250234 |
| --- | --- |
| Trade/ Device Name: | SMARTeZ™ Elastomeric Infusion Pump (RS) |
| Common/ Usual Name: | Pump, Infusion, Elastomeric |
| Regulation Number: | 21 CFR 880.5725 |
| Regulation Name: | Infusion Pump |
| Regulatory Class: | Class: II |
| Product Code: | MEB |
## III. Predicate
| 510(k) Number: | K151650 |
| --- | --- |
| Trade/ Device Name: | SMARTeZ™ Elastomeric Infusion Pump |
| Common/ Usual Name: | Pump, Infusion, Elastomeric |
| Regulation Number: | 21 CFR 880.5725 |
| Regulation Name: | Infusion Pump |
| Regulatory Class: | Class: II |
| Product Code: | MEB |
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EPIC
## IV. Purpose of Submission and Device Description
The SMARTeZ™ Elastomeric Infusion Pump (RS), SMARTeZ™ RS, or RS Pump, is a sterile, single-use, non-electronic elastomeric infusion pump designed for continuous drug delivery. It utilizes a self-pressuring elastomeric reservoir as its energy source, which drives the fluid through an integrated administration line and flow restrictor to the patient connection. The device is intended exclusively for infusion therapy and not for fluid storage.
The Submission introduces a new series within the SMARTeZ™ product family (previously cleared under K151650 and K242152), expanding the portfolio with enhanced structural features and consistent performance characteristics.
All SMARTeZ™ infusion pumps operate on the same physical principle: flow control is achieved via a restriction in the inner diameter of the tubing, while the elastomeric reservoir provides the energy for fluid delivery. When filled, the reservoir membrane stretches, and its elastic recoil drives the fluid through the tubing and flow restrictor to the patient.
These differences do not introduce new questions of safety or effectiveness and are supported by analytical and functional testing, as detailed in Section VI.
## V. Indications for Use Statement
The SMARTeZ Pump (Long infusion time article) is intended for continuous infusion of medications for general infusion use, including pain management.
- Routes of administration: intravenous and subcutaneous.
The SMARTeZ Pump (Short infusion time article) is intended for continuous infusion of medications for general infusion use, including antibiotic delivery.
- Route of administration: intravenous.
The SMARTeZ Pump (Chemotherapy article) is intended for continuous infusion of chemotherapy medications.
- Routes of administration: intravenous and intra-arterial.
## VI. Comparison of Intended Use & Technological Characteristics
The Subject device and the Predicate device share the following characteristics:
### Intended Use comparison
1) Indications for use statement
2) Primary product code and regulation number
3) Intended user population/ intended use environment
4) Intended drug type
5) Types of infusion therapies
6) Routes of infusion
7) Medical delivery method
8) Prescription use or over-the-counter use
### Technological Characteristics comparison
### Equivalencies – Technology & Design
The Subject device and the Predicate device share the following design characteristics:
1) Principles of operation
2) Energy source
3) Particle filter pore size
4) Performance specifications
5) Sterile barrier packaging
6) Sterilization process
7) Shelf-life
8) Single use or reusable
9) Labeling specifications
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EPIC
In addition to standard risk management, a Safety Assurance Case was included in this Submission to support the safety and performance of the SMARTeZ™ RS, in alignment with US FDA’s Infusion Pump Improvement Initiative. An overview table summarizing the comparison of the key characteristics between the Subject and the Predicate device is provided hereunder:
Comparison of intended use characteristics and the technological characteristics
| Characteristic compared | Predicate Device (K151650)
SMARTeZ™ Elastomeric Infusion Pump | Subject Device (K250234)
SMARTeZ™ Elastomeric Infusion Pump (RS) | Comment/ Discussion |
| --- | --- | --- | --- |
| Intended use and Indications for Use statement | The SMARTeZ Pump (Long infusion time article) is intended for continuous infusion of medications for general infusion use, including pain management.
• Routes of administration: intravenous and subcutaneous.
The SMARTeZ Pump (Short infusion time article) is intended for continuous infusion of medications for general infusion use, including antibiotic delivery.
• Route of administration: intravenous.
The SMARTeZ Pump (Chemotherapy article) is intended for continuous infusion of chemotherapy medications.
• Routes of administration: intravenous and intra-arterial. | | Same |
| Primary product code and regulation number | MEB
21 CFR 880.5725 | | Same |
| Intended user population/ intended use environment | Adequately trained health care professionals/ clinical setting | | Same |
| Intended drug type | Parenteral drugs | | Same |
| Types of infusion therapies | 4 types: General infusion including chemotherapy, analgesia and antibiotic therapy | | Same |
| Routes of infusion | 3 types: IV, IA, subcutaneous | | Same |
| Medical delivery method | Continuous fixed flow rate | | Same |
| Prescription use or over-the-counter use | R only | | Same |
| Principles of operation | Hagen-Poiseuille law | | Same |
| Energy source | Constriction of elastomeric membrane of fluid reservoir | | Same |
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EPIC
Comparison of intended use characteristics and the technological characteristics
| Characteristic compared | | Predicate Device (K151650) SMARTeZ™ Elastomeric Infusion Pump | Subject Device (K250234) SMARTeZ™ Elastomeric Infusion Pump (RS) | Comment/ Discussion |
| --- | --- | --- | --- | --- |
| Device construction | Device components | Fluid reservoir, administration tube, flow restrictor, distal connector with safety closing cap, made of plastics and elastomer
Fill port: Check valve, female Luer lock
Fluid reservoir: Elastomeric silicone rubber membrane
Administration tubing: Included in the device, together with air and particulate filter.
Kink-resistant PVC infusion line not made with DEHP (Di(2-ethylhexyl)phthalate).
Flow restrictor: Plastic micro bore tube, and plastic capillary tube | | Same |
| | Outer shell | Soft outer shell | Hard outer shell | Different, see Comment #1 |
| | Inline Fill Port & TPU Tube (clamp portion of tube) | Do not not exist | Are present | Different, see Comment #2 |
| Particle filter pore size | | 1.2 μm | | Same |
| Performance specifications | | ISO 28620:2020, Medical devices — Non-electrically driven portable infusion devices | | Same |
| Sterile barrier packaging | | Medical grade paper and medical plastic film, heat sealed | | Same |
| Sterilization process | | Ethylene Oxide (EO), SAL 10⁻⁶ | | Same |
| Shelf-life validation | | 3 years (36 months) | | Same |
| Single use or reusable | | Single use only | | Same |
| Labeling specifications | | Met the requirements specified in 21 CFR 801 | | Same |
## Submitter's Comments
Comment #1
Subject device incorporates a hard outer shell compared with Predicate device which incorporates a soft outer shell. This difference between the Subject device and Predicate device did not raise different questions of safety and effectiveness as analytical and functional testing have also been conducted and the functional performance data are summarized in subsection VII.A – Functional Performance. The analytical aspects are presented in VII.B – Biocompatibility
Comment #2
Subject device incorporates an Inline Valve Fill Port and a TPU Tube and as compared with Predicate device, these subcomponents do not exist. This difference between the Subject device and Predicate device did not raise different questions of safety and effectiveness as analytical and functional testing have also been conducted. The functional performance data are summarized in subsection VII.A – Functional Performance and the biocompatibility testing and chemical characterization data are summarized in subsection VII.B – Biocompatibility
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EPIC
## VII. Performance Data Supporting Substantial Equivalence
### A. Functional Performance
The Subject device was evaluated to be in conformance with the following ANSI/AAMI and ISO standards and product code-applicable FDA’s guidance document:
- ANSI/AAMI CN27:2021 – General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
- ISO 80369-7:2021 – Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- ISO 80369-20:2015 – Small-bore connectors for liquids and gases in healthcare applications (Part 20: Common test methods)
- ISO 28620:2020 – Medical devices — Non-electrically driven portable infusion devices
- Infusion Pumps Total Product Life Cycle – Guidance for Industry and FDA Staff (2014)
Comprehensive bench performance verification and validation testing was performed on the Subject device and the Predicate device (K151650) to demonstrate substantial equivalence and compliance with applicable guidance:
- Leak-proof tests under these conditions – i) after resistance to pressure test (on Subject device), ii) after accelerated ageing and resistance to pressure test (on Subject device), iii) after drop test (on Subject device), iv) after resistance to traction test (on Subject device), v) after drop test and storage for 12 hours (on Subject device), vi) after refrigeration; to ISO 28620:2020, subclause 6.3, 6.4, 6.5 & 6.6 (under K151650)
- Flow rate tests under these conditions – i) under nominal condition, mean flow rate within ± 15% of the nominal flow rate and ≥ 80% of nominal flow rate delivered at an instantaneous flow rate within ± 50% of the nominal flow rate (on Subject device), ii) after accelerated ageing, mean flow rate within ± 15% of the nominal flow rate and ≥ 80% of nominal flow rate delivered at an instantaneous flow rate within ± 50% of the nominal flow rate (on Subject device), iii) delivery of normal saline 0.9% at 31°C with pump positioned at 40 cm below the catheter site, mean flow rate within ± 15% of the nominal flow rate and ≥ 80% of nominal flow rate delivered at an instantaneous flow rate within ± 50% of the nominal flow rate (on Subject device), iv) after resistance to pressure test, mean flow rate within ± 15% of the nominal flow rate and ≥ 80% of nominal flow rate delivered at an instantaneous flow rate within ± 50% of the nominal flow rate (on Subject device), v) after accelerated ageing and resistance to pressure test, mean flow rate within ± 15% of the nominal flow rate and ≥ 80% of nominal flow rate delivered at an instantaneous flow rate within ± 50% of the nominal flow rate (on Subject device), vi) after refrigeration, under non-ambient pressure (simulating influences of routes of administration); to ISO 28620:2020, subclause 6.2 & 6.6 (under K151650)
- Retrograde flow of infusate tests (under K151650)
- Luer lock connection tests on the new Luer lock connectors – i) positive pressure fluid leakage test, ii) sub-atmospheric pressure air leakage test, iii) stress cracking test, iv) resistance to separation from axial load test, v) resistance to separation from unscrewing test, vi) resistance to overriding test, to ISO 80369-7:2021 performed on the Subject device
### B. Biocompatibility
In accordance with ISO 10993-1:2018, the Subject device, like the existing SMARTeZ™ Pump, is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hr to 30d). The following testing were conducted on the Subject device:
- Cytotoxicity to ISO 10993-5:2009
- Sensitization to ISO 10993-10:2010
- Intracutaneous Reactivity to ISO 10993-23:2021
- Acute Systemic Toxicity to ISO 10993-11:2017
- Subacute/Subchronic Systemic Toxicity to ISO 10993-11:2017
- In-vitro Hemolysis to ISO 10993-4:2017
- Material Mediated Pyrogenicity to ISO 10993-11:2017
- Chemical Characterization and Toxicological Risk Assessment to ISO 10993-18:2020 & ISO 10993-17:2002
- Particulate Matter to ISO 8536-4:2019, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed and USP <788> Particulate Matter in Injections
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EPIC
## C. Sterility, Shipping, and Shelf-Life
The Subject SMARTeZ™ RS, like the existing SMARTeZ™ Pump, complies with sterilization requirements of ISO 11135:2014, Sterilization of Health Care Products – Ethylene Oxide – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices and the following testing/evaluations:
- Simulated shipping testing per ASTM D 4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems under K151650
- Package integrity tests per ASTM F1980-21, Standard guide for accelerated aging of sterile barrier systems for medical devices and Sterile Barrier Packaging Testing performed on the proposed device: Seal strength – ASTM F88/F88M-21, Standard test method for seal strength of flexible barrier materials; Dye Penetration – ASTM F1929-23, Standard test method for detecting seal leaks in porous medical device packaging by dye penetration; EN 868-5:2009, Packaging materials and systems for medical devices which are to be sterilized – Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction – Requirements and test methods under K151650
- Pyrogen tests per ANSI/AAMI ST72/2019, Bacterial endotoxins – Test methods, routing monitoring, and alternatives to batch testing, USP 42-NF 37 <151>, Pyrogen test (USP rabbit test), USP 42-NF 37 <161>, Medical Devices-Bacterial Endotoxin and Pyrogen Tests, USP 42-NF 37 <85>, Bacterial Endotoxins Test under K151650 and testing will be conducted on every lot
- Shelf-life of 3 years has been validated using the FDA recognized standard, ASTM 1980-21, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices under K151650
## VIII. Clinical Tests
Not applicable
## IX. Conclusion
Based on the comparative analysis and performance data, the SMARTeZ™ Elastomeric Infusion Pump (RS) submitted under K250234 does not raise new questions of safety or effectiveness. Therefore it is substantially equivalent to the Predicate device, SMARTeZ™ Elastomeric Infusion Pump (K151650), per US FDA 510(k) requirements
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